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Brand Name:ENDOWRISTDevice Problem: CrackPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, CUSTOMER REPORTS, TISSUE WAS GETTING CAUGHT IN THE EDGE OF THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WHERE THE SHAFT MEETS THE BIPOLAR. T... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI VESSEL SEALER EXTEND (VSE) TO PERFORM FAILURE ANALYSIS. THE VSE WAS ANALYZED AND THE COMPLAINT REGARDING TISSUE WAS GETTING CAUGHT I... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED BILATERAL INGUINAL HERNIA REPAIR, THE FORCE BIPOLAR FORCEPS (FBF) BROKE AND HAD TO BE REMOVED WITH THE CANNULA. DURING FOLLOW UP WITH THE SITE, THE FO... | BASED ON THE CURRENT INFORMATION PROVIDED, THE REPORTED COMPLAINT CANNOT BE CONFIRMED. THE FORCE BIPOLAR INSTRUMENT WAS RETURNED TO INTUITIVE SURGICAL, INC. (ISI) AND FAILURE ANALYSIS (FA) COULD NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN HOUSE SYSTEM. THE IN... |
Brand Name:DAVINCI XDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SYSTEM EXPERIENCED A REPEATING RECOVERABLE FAULT 32097. THE ERROR WAS POINTING TOWARDS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SYSTEM EXPERIENCED A REPEATING RECOVERABLE FAULT 32097, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGAT... |
Brand Name:NONEDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT JAW ON THE SHEARS FELL OFF. THE PIECE AND INSTRUMENT WERE REMOVED FROM THE PAT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE JAW FELL INTO THE PATIENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE... |
Brand Name:NONEDevice Problem: Unintended MovementPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA PARAESOPHAGEAL SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE ENDOSCOPE THAT WAS INSTALLED IN THE UNIVERSAL SURGICAL MANIPULATOR (US... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING MOVED BACK TO THE TOP OF THE RANGE WHILE THE SURGEON WAS OPERATING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE UNSPECIFIED INSTRUMENT BROKE, WITH SHARDS COMING OFF OF THE SHAFT INSIDE OF THE PATIENT. AN INTUITIVE SURGICAL, INC. (IS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT AN UNSPECIFIED INSTRUMENT BROKE INTO THE PATIENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE TECHNICAL SUPPORT ENGINEER (TSE) RECOMMENDED THAT THE CUSTOMER RETURN THE BROKEN INSTRUMENT AND TROCAR TO PREVENT FURTHE... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAD SMALL HOLE ON THE COATING OF SHAFT BEYOND SCISSO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE DAMAGED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE HAS RECEIVED MCS INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. FAILURE ANALYSIS INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CU... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD POSSIBLE BURN MARKS ON THE INSULATION. THE PROCE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BURN MARKS ON INSULATION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND ... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS MOVEMENT ARE SLOW OR INTERMITTENT. THE INSTRUMENT WAS EXCHANGED... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED, AND FAILURE A... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THE SURGICAL PROCEDURE, 0-DEGREE ENDOSCOPE'S IMAGE WOULD FLIP ON SCREEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE S... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING IMAGE FLIP ON SCREEN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE 0-DEGREE ENDOSCOPE WAS ANALYZED AND FOUND TO HAVE SCOPE BEARING... |
Brand Name:ENDOWRISTDevice Problem: Entrapment of Device; Difficult to Open or ClosePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY PROCEDURE, THE FORCE BIPOLAR INSTRUMENT WAS STUCK ON TISSUE, THE INSTRUMENT RELEASE KEY WAS USED UNSUCCESSF... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FORCE BIPOLAR INSTRUMENT ASSOCIATED WITH THIS COMPLAINT, AND A FAILURE ANALYSIS (FA) INVESTIGATION WAS COMPLETED. THE FA INVESTIGATION REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COMPLAINT, WITH THE PRIMARY FAILURE OF "BENT GRIPS." THE INSTRUMENT WAS FOUND TO HAVE A BENT G... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTS ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE... |
Brand Name:DAVINCI SIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER CALLED IN TO REPORT AN "ILLUMINATOR LAMP MODULE ERROR..." MESSAGE DISPLAYED WHEN REPLACING THE L... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE "ILLUMINATOR LAMP MODULE ERROR..." MESSAGE OCCURRED, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE ... |
Brand Name:DA VINCIDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING AN UNSPECIFIED DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT WAS BROKEN WHILE GRASPING TISSUE. THE INSTRUMENT FRAGMENTS FELL IN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE HARMONIC ACE INSERT WAS BROKEN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HARMONIC ACE INSERT WAS ANALYZED AND THE COMPLAINT R... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT MOVING UP AND DOWN. THE PROCEDURE WAS COMPLETED WITH N... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NOT MOVING UP AND DOWN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS (FA). THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND ... |
Brand Name:DAVINCI XIDevice Problem: Defective DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE INFORMED THE TECHNICAL SUPPORT ENGINEER... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING E-100 GENERATOR WOULD NOT POWER ON, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. TH... |
Brand Name:NONEDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In Patient; No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BROKE AND A PIECE FELL INSIDE THE PATIENT DURING IN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER PHYSICAL DAMAGE ON THE INSTRUMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS I... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED DURING A DA VINCI-ASSISTED VENTRAL HERNIA TAPP SURGICAL PROCEDURE, CUSTOMER REPORTS A MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT WAS INSTALLED, HAD ONE MORE USE, ¿GOBBLE A ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A FRAGMENT FELL INTO THE PATIENT, AN INVESTIGATION IS PENDING TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE MEGA SUTURECUT NEEDLE DRIVER INSTRUMENT, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. A FOLLOW-UP ... |
Brand Name:NONEDevice Problem: Detachment of Device or Device Component; Material Integrity ProblemPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY HAD TEARS AND DETACHED FR... | BASED ON THE CLAIM AGAINST THE PRODUCT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. BASED ON TH... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY-RADICAL WITH LYMPHADENECTOMY SURGICAL PROCEDURE, AN INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING IMAGE WAS INVERTED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. AN RMA WAS NOT ISSUED FOR RETURN AS THE C... |
Brand Name:DA VINCI ENERGYDevice Problem: ArcingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT A MESSAGE REGARDING E-100 GENERATOR BEING NOT DET... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE SYNCHROSEAL INSTRUMENT ARCED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. TSE CONFIRMED THAT THE E-100 AUTOMATICALLY SHUTTING DOWN IS A MITIGATION AND IS AN EXPECTED ACTION WHEN A CONDITION I.E. ARCING IS DETECTED. ... |
Brand Name:ENDOWRISTDevice Problem: Energy Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND INSTRUMENT WAS UNABLE TO CAUTERIZE. THERE WAS NO GOOD CONTACT. THE PROCEDUR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING INSUFFICIENT SEAL, AN INVESTIGATION IS IN PROGRESS. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER ... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, ERROR C-34 OCCURRED ON AN INTEGRATED ELECTROSURGICAL UNIT (IESU) WHEN THE CUSTOMER WAS ATTEMPTING TO USE THE MONOPOLAR COAG ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR C-34, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN ISI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. DURING FIELD EVALUATION, THE FSE CONDUCTED AN INSPECT... |
Brand Name:NONEDevice Problem: Use of Device Problem; Improper or Incorrect Procedure or MethodPatient Problem: Bone Fracture(s)Event Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED MEDIASTINAL LYMPH NODE DISSECTION, THE TROCAR BROKE A PIECE OF THE PATIENT'S RIB WHILE MOVING AN INSTRUMENT ON UNIVERSAL SURG... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE TROCAR INJURY IS UNKNOWN. IT WAS REPORTED THAT THE TROCAR WAS NOT PLACED PROPERLY, INTERVENTION INCLUDED PUSHING IT IN FARTHER. THE PRODUCT HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. REVIEW OF THE SYSTEM LOGS SHOWED THERE WERE NO S... |
Brand Name:ENDOWRISTDevice Problem: Difficult to RemovePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CLIP APPLIER WOULD NOT RELEASE THE CLIP. THE CLIP APPLIER WORKED ON THE FIRST TWO CLIP APPLICATIONS ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE CLIP APPLIER WOULD NOT RELEASE THE CLIP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE MEDIUM-LARGE CLIP APPLIER WAS ANALYZED AND FOUND TO HAVE A FAILED CLIP TEST DUE TO MISAPPLICATION OF THE CLIP. THE INSTRUMENT WAS P... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THE SURGICAL PROCEDURE, THE JAWS OF THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT STOPPED WORKING AND WOULD NOT OPEN. THE CUSTOMER REMOVED... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING JAWS NOT OPENING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE... |
Brand Name:NONEDevice Problem: BreakPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSULATION AT THE FRONT OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIP COVER ACCESSORY WAS DEFECTIVE. THE PROCEDURE WAS COMPLETED... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT THAT ¿THE INSULATION AT THE FRONT OF THE MCS WAS DEFECTIVE¿. FAILURE ANALYSIS FOUND THE P... |
Brand Name:DAVINCI XDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY - MALIGNANT SURGICAL PROCEDURE, INTUITIVE SURGICAL, INC. (ISI) CLINICAL SALES REPRESENTATIVE (CSR) REPORTED, UNIVERSAL SURGICAL MANI... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SET UP JOINT (SUJ) ASSEMBLY INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT REPRODUCE THE CUSTOMER REPORTED COMPLAINT. HOWEVER, THE REPORTED FAILURE WAS CONFIRMED THROUGH ERROR LOGS. ACCORDING TO THE REPORT, THE ... |
Brand Name:DAVINCI XIDevice Problem: Failure to Deliver EnergyPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HEMICOLECTOMY - RIGHT SURGICAL PROCEDURE, THE VESSEL SEALER INSTRUMENT WOULD NOT CONNECT TO E100 GENERATOR. THE CUSTOMER BELIEVED THA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CONNECTION ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS ABLE TO ... |
Brand Name:NONEDevice Problem: No Display/ImagePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE HANDHELD CAMERA WILL NOT SHOW A PICTURE AND THERE WAS A BLACK SCREEN. THE PROCEDURE WAS CONVERTED TO ANOTHER DV SYSTEM WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (I... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NOT SHOW A PICTURE AND THERE WAS A BLACK SCREEN, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE HANDHELD CAMERA ACCESSORY WAS ANALY... |
Brand Name:ENDOWRISTDevice Problem: Defective ComponentPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY WEDGE RESECTION PROCEDURE AND UPON INSERTION OF THE TIP-UP FENESTRATED GRASPER INSTRUMENT, TISSUE BECAME STUCK NEAR THE WRIST OF THE INSTRUMENT, C... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. THE TIP-UP FENESTRATED GRASPER INSTRUMENT HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION AND HAS BEEN USED IN SUBSEQUENT PROCEDURES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL IN... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE'S IMAGE WAS UPSIDE DOWN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE 30-DEGREE ENDOSCOPE'S IMAGE WAS UPSIDE DOWN, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DEVICE RECEIVED THE ENDOSCOPE, BUT FAILURE ANALYSIS HAS NOT BEEN COMPLETED. A SUPPLEMENTAL MDR WILL... |
Brand Name:DAVINCI XIDevice Problem: Energy Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE BIPOLAR ENERGY LEVEL WAS SET TO FOUR AND THE SURGEON WAS NOT GETTING PROPER ENERGY. THE CUSTOMER ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE EXTERNAL FOOT PEDAL WAS NOT WORKING, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVEN... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED TECHNICAL SERVICE ENGINEER (TSE) AND REPORTED AN ONGOING ERROR ON ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ONGOING ERBE GENERATOR ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. FSE R... |
Brand Name:ENDOWRISTDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SEGMENTAL PANCREATECTOMY PROCEDURE, THE PATIENT EXPERIENCED BLEEDING AND THE PROCEDURE WAS CONVERTED TO OPEN. THE FOLLOWING INFORMATION WAS OBTAIN... | BASED ON INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE BLEEDING CANNOT BE DETERMINED. THE ROBOTICS COORDINATOR STATED THAT NO DAVINCI INSTRUMENT, SYSTEM, OR ACCESSORY CAUSED OR CONTRIBUTED TO THE EVENT. THE CADIERE FORCEPS INSTRUMENT WAS RETURNED FOR EVALUATION AND WAS FOUND TO BE FULLY FUNCTIONAL. FAILURE ANA... |
Brand Name:NONEDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS TORN AT THE TIP. THE CUSTOMER REPLACED THE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS TORN, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE MCS TIP COVER ACCESSORY FOR EVALUATION. THEREFORE, THE R... |
Brand Name:NONEDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER STATED THE 30 DEGREE ENDOSCOPE WAS NOTED TO BE DEFECTIVE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. IN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A DEFECTIVE 30 DEGREE ENDOSCOPE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS FOUND SEVERE DAMAGE ON CABLE JACKET. TH... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM 4) WAS GETTING TEMPERATURE ERRORS. INTUITIVE SURGICAL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING TEMPERATURE ERRORS, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED ... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL BILATERAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A C-34 ERROR ON THE ERBE GENERATOR. PRIOR TO CALLING IN, THE CALLER CHANG... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED C-34 ERRORS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED... |
Brand Name:DAVINCI XIDevice Problem: Physical Resistance/StickingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS EXPERIENCING RESISTANCE ON INSERTION AXIS. AN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING USM HAD RESISTANCE ON INSERTION AXIS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. ... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED INJURY. INT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MEDIUM-LARGE CLIP APPLIER WOULD NOT OPEN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WA... |
Brand Name:SUREFORMDevice Problem: Difficult to Remove; Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRECTOMY SURGICAL PROCEDURE, THE CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER (TSE) THAT SUREFORM 45 STAPL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT SURE FORM 45 STAPLER FAILED TO FIRE AND FAILED TO UNCLAMP, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED T... |
Brand Name:SUREFORMDevice Problem: Difficult to Open or Close; Patient Device Interaction ProblemPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PATIENT UNDERWENT A CONVERSION TO OPEN SURGERY. THE ISSUE OCCURRED WHEN THE SUR... | ON 27-APR-2023, THE FOLLOWING ADDITIONAL INFORMATION ABOUT THE REPORTED EVENT WAS OBTAINED: THE SUREFORM 45 WHITE RELOAD WAS RECEIVED AND INVESTIGATIONS WERE COMPLETED. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED AND REPLICATED THE CUSTOMER REPORTED COMPLAINT. THE RELOAD WAS FOUND TO HAVE A FIRING FAILURE BASED ON LOG RE... |
Brand Name:DAVINCIDevice Problem: Insufficient InformationPatient Problem: Hemorrhage/Bleeding; Urinary Tract Infection; Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI ASSISTED HYSTERECTOMY PROCEDURE IN (B)(6) 2004, WHICH WAS PERFORMED FOR LARGE FIBROID TUMORS, THE PATIENT DISCOVERED ... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATIONS ARE UNKNOWN. INTUITIVE SURGICAL, INC. (ISI) HAS ATTEMPTED TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THE FOLLOWING INFORMATION IS UNKNOWN: THE EVENT DATE, SURGEON NAME, AND DA VINCI SYSTEM INFORMATION. HOWEVER, AS OF... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ADRENALECTOMY SURGICAL PROCEDURE, A NON-INTUITIVE MOVEMENT WAS NOTED ON THE UNIVERSAL SURGICAL MANIPULATOR (USM4), WHERE THE MONOPOLAR CU... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE CAMERA MOVED SUDDENLY WITH AN ANGLE DIFFERENCE OF 90° COMPARED TO THE DESIRED MOVEMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSI... |
Brand Name:FLEXISIONDevice Problem: Unintended MovementPatient Problem: Chest Pain; PneumothoraxEvent Description: IT WAS REPORTED THAT AFTER AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX DUE TO THE 21G FLEXISION BIOPSY NEEDLE SHEATH MOVING 3 CENTIMETERS (CM) PAST THE CATHETER. THE NEED... | FURTHER DEVICE EVALUATION WAS DONE BY INTUITIVE SURGICAL, INC. (ISI) ADVANCED FAILURE ANALYSIS ENGINEER AND THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE NEEDLE WAS EXTENDED AND RETRACTED. THE NEEDLE WAS OBSERVED TO HAVE AN INTERMITTENT NEEDLE RETRACTION FAILURE. THE NEEDLE WAS ABLE TO FULLY RETRACT WHEN IT WA... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PEDIATRIC CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WOULD NOT RELEASE. THE P... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WOULD NOT RELEASE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE CLIP APPLIER WAS ANALYZED... |
Brand Name:ENDOWRIST;DAVINCI SIDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT JAWS STOP WORKING AND WERE NOT OPENING. THE INS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSTRUMENT JAWS WERE NOT OPENING, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ISI H... |
Brand Name:DA VINCIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Wound Dehiscence; Hemorrhage/BleedingEvent Description: INTUITIVE SURGICAL INC (ISI) WAS MADE AWARE OF A SOCIAL MEDIA POST INDICATING THAT 4-5 WEEKS AFTER A DA-VINCI ASSISTED HYSTERECTOMY, THE PATIENT EXPERIENCED V... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE VAGINAL CUFF TEAR CANNOT BE DETERMINED. THERE WAS NO CLAIM AGAINST THE PRODUCT AND NO INDICATION OF A PRODUCT ISSUE, AND THUS THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE REPORTED EVENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE FORCE BIPOLAR INSTRUMENT WAS INTRODUCED INTO THE PATIENT, BUT THE SURGEON WAS UNABLE TO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNCLAMPING ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS DID N... |
Brand Name:DAVINCI SIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SALPINGO OOPHORECTOMY SURGICAL PROCEDURE, THE SYSTEM WAS GETTING REPEATED RECOVERABLE FAULTS 48238 THAT TURNED INTO A NON-RECOVER... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED RECOVERABLE 48238 FAULT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASE... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED A TECHNICAL SUPPORT ENGINEER (TSE) AND R... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ERROR 319, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED THE UNI... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, DESPITE PROPER USE, THE BRANCH OF THE FENESTRATED BIPOLAR FORCEPS (FBF) BROKE OFF DURING IN SI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT A FRAGMENT FELL OFF THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE, BUT IT... |
Brand Name:DAVINCI XIDevice Problem: Physical Resistance/StickingPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SUBTOTAL GASTRECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD ISSUES WITH UNIVERSAL SURGICAL MANIPULATOR (USM) 4 GETTING STUCK. THE CARR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING STUCK, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE FOUND THAT THE VERTICA... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED COLORECTAL SURGICAL PROCEDURE, THERE WAS A LOT OF MOTION ON THE SURGEON SIDE WITH THE 30-DEGREE ENDOSCOPE FLIPPING ON THEM WITHOUT USER I... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE 30-DEGREE ENDOSCOPE FLIPPING ON THEM, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE ENDOSCOPE, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMI... |
Brand Name:NONEDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIP COVER ACCESSORY WAS TORN AT THE TIP. THE CUSTOMER REPLACED THE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE MCS TIP COVER ACCESSORY WAS TORN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MCS TIP COVER ACCESSORY WAS ANALYZED A FOU... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL UNILATERAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED NON-RECOVERABLE FAULTS. THE OPERATING ROOM (OR) STAFF WER... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-RECOVERABLE FAULTS AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WENT ON... |
Brand Name:ENDOWRISTDevice Problem: Difficult to RemovePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA TRANSVERSUS ABDOMINIS RELEASE (TAR) SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT GOT STUCK IN THE TROCAR. T... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING FENESTRATED BIPOLAR FORCEPS GOT STUCK IN THE TROCAR, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE ... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, A WIRE OF THE SMALL GRASPING RETRACTOR INSTRUMENT SNAPPED. THE PROCEDURE WAS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE SMALL GRASPING RETRACTOR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BRO... |
Brand Name:ENDOWRIST SPDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SU... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN OR LOOSE CABLE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS WAS ANALYZED AND FOUND THAT FAILURE... |
Brand Name:DAVINCI XIDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT SURGICAL PROCEDURE, THERE WAS UNEXPECTED MOVEMENT ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1 ON S... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THERE WAS UNEXPECTED MOVEMENT ON USM 1, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONTACTED THE ISI CLINI... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA PROCEDURE, THE JAWS OF A FORCE BIPOLAR INSTRUMENT WAS STUCK ON TISSUE WHILE PULLING ON THE HERNIA SAC. THE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE JAWS OF A FORCE BIPOLAR INSTRUMENT (PART# 471405-6 | SERIAL#: (B)(4)) WAS STUCK ON TISSUE, INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FORCE BIPOLAR (FB) INSTRUMENT TO PERFORM FAILURE ANALYSIS. FAILURE ANALYSIS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER ... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, NON-INTUITIVE MOTION OCCURRED WITH A MARYLAND BIPOLAR FORCEPS. THE CUSTOMER HAD REPLACED THE INSTRUMENT WITH A BACK... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN INTUITIVE SURGICAL, INC (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSIS... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT'S WRIST DID NOT MOVE PROPERLY. THE PROCE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING WRIST NOT MOVING PROPERLY, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE D... |
Brand Name:DAVINCI XIDevice Problem: Physical Resistance/StickingPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA ETEP PROCEDURE, THE CLINICAL SALES REPRESENTATIVE (CSR) CONTACTED THE TECHNICAL SUPPORT ENGINEER (TSE) FROM OFFSITE AND INFORMED TH... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CONVERSION OF THE PROCEDURE WAS CONTRIBUTED BY ANATOMICAL FACTORS AND DRAPE ISSUE LIMITING ARM INSERTION AS PER THE SURGEON. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SUBMITTED. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCL... |
Brand Name:DAVINCI XDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SALPINGO-OOPHORECTOMY PROCEDURE, THE CUSTOMER INFORMED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) THAT A ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED RECOVERABLE FAULT 23072 AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE I... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED A REPEATED NON-RECOVERABLE 319 FAULT ON UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED NON-RECOVERABLE 319 ERRORS ON THE UNIVERSAL SURGICAL MANIPULATOR (USM) 3, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SIT... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SYSTEM TRIGGERED RECOVERABLE FAULT 23094. PRIOR TO CALLING FOR TECHNICAL SUPPORT, THE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE END OF THE SURGERY SYSTEM TRIGGERED RECOVERABLE FAULT 23094, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INVESTIG... |
Brand Name:ENDOWRISTDevice Problem: Defective DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THE FORCE BIPOLAR BROKE ON ARM #1. IT WAS NOTED THAT THE JAWS OF THE INSTRUMENT WERE BROKEN BUT NOT DETACHED... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. ISI REQUESTED THE CUSTOMER RETURN THE FORCE BIPOLAR INSTRUMENT USED DURING THIS EVENT, BUT THE PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. AN INTUITIVE SUR... |
Brand Name:DAVINCI XIDevice Problem: Failure to SensePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT HEMICOLECTOMY SURGICAL PROCEDURE, THE SYSTEM HAD ENGAGEMENT ISSUES WITH A SUREFORM 60 STAPLER INSTRUMENT. AFTER MULTIPLE ATTEMPTS, THE C... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. THE CUSTOMER CONFIRMED THAT BOTH STAPLERS INSTRUMENTS ALONG WITH THE DRAPE WILL BE RETURNED TO ISI FOR FAILURE ANALYSIS EVALUATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE CUSTO... |
Brand Name:SUREFORMDevice Problem: Adverse Event Without Identified Device or Use Problem; Patient Device Interaction ProblemPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, WHILE USING A SUREFORM 60 STAPLER INSTR... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. A PRODUCT HAS NOT BEEN RETURNED TO ISI FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. AN ADVANCED REVIEW OF THE DEVICE LOGS WAS CONDUCTED BY AN INTUITIVE SURGICAL, INC... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WHITE PLASTIC (INSULATION) WAS DEFECTIVE. NO FRAGMENTS FELL INTO THE PATIENT. THE PRO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSTRUMENT THE WHITE PLASTIC (INSULATION) WAS DEFECTIVE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORC... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO START, POST ANESTHESIA OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYSTEM HAD AN ERROR 319. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENG... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR 319, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE RESET THE FIBER CO... |
Brand Name:ENDOWRISTDevice Problem: Energy Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT DID NOT CAUTERIZE. THE PROCEDURE WAS ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CAUTERY ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE ... |
Brand Name:NONEDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHROURETERECTOMY SURGICAL PROCEDURE, CLINICAL TERRITORY ASSOCIATE (CTA) REPORTED THAT A 30-DEGREE ENDOSCOPE FLIPPED DIRECTION ON ITS OWN. ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE 30 DEGREE ENDOSCOPE FLIPPED DIRECTION ON ITS OWN DURING CASE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER WAS ABLE TO USE A BACKUP ENDOSCOPE TO COMPLETE T... |
Brand Name:SINGLE-SITEDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE PLASTIC PART AROUND THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TIP WAS BROKEN. A B... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE PLASTIC PART AT THE INSTRUMENT TIP WAS BROKEN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRU... |
Brand Name:ENDOWRISTDevice Problem: Material Integrity ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CLIP WOULD NOT DEPLOY FROM THE MEDIUM-LARGE CLIP APPLIER. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MEDIUM-LARGE CLIP APPLIER WOULD NOT DEPLOY THE CLIP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER WA... |
Brand Name:ENDOWRISTDevice Problem: Difficult to RemovePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL GASTRECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FAILED TO RELEASE ONE SIDE OF THE CLIP AFTER CLOSURE. THE CL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CLIP APPLICATION FAILURE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE ONE GRIP BENT. THE... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT'S CABLE BROKE OFF. THE PROCEDURE WAS COMPLETED WITH N... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN CABLE, AN INVESTIGATION IS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. ISI DID RECEIVE DA VINCI PRODUCT FOR FAILURE ANALYSIS. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE... |
Brand Name:DAVINCI XIDevice Problem: No Display/ImagePatient Problem: Unspecified Respiratory ProblemEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ADRENALECTOMY SURGICAL PROCEDURE, THE RIGHT EYE OF THE SURGEON SIDE CONSOLE (SSC) WENT BLACK ABOUT 2.5 HOURS AFTER THE START OF THE PROCEDURE. PRIOR TO ... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE RESPIRATORY COMPLICATION CANNOT BE DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INVESTIGATE THE REPORTE... |
Brand Name:DAVINCI XIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT DURING A DAVINCI-ASSISTED THORACOSCOPIC MITRAL VALVULOPLASTY, THERE WAS "MASSIVE BLEEDING" AFTER THE ROBOTIC PORTION OF THE PROCEDURE "WAS COMPLETED AND ... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. A PRODUCT HAS NOT BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A REVIEW OF THE SITE¿S SYSTEM LOGS WAS CONDUCTED, AND ... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS HAD GRIP FAILURE ISSUES. ALSO, THE FENESTRATED BIPOLAR FORCEP... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE FENESTRATED BIPOLAR FORCEPS HAD GRIP ISSUES AND BROKE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEP... |
Brand Name:DA VINCI XIDevice Problem: No Device OutputPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE PATIENT SIDE CART (PSC) ARMS WERE NOT STEERABLE FROM THE SURGEON SIDE CART (SSC). THE INTUITIVE SURGICA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ARM NOT RESPONSIVE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE COULD NOT ... |
Brand Name:NONEDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT THE PATIENT UNDERWENT A DA VINCI-ASSISTED HYSTERECTOMY PROCEDURE ON (B)(6) 2022. THE PATIENT COMPLAINED OF INTERMITTENT PAIN FOR FEW WEEKS. RADIOGRAPHIC SCAN WAS PERFORM... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) HAS NOT RECEIVED THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT AND TIP COVER ACCESSORY INVOLVED WITH THIS EVENT FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF AD... |
Brand Name:ENDOWRIST SPDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY SURGICAL PROCEDURE, THE TIP OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS DAMAGED, AND A FRAGMENT FELL. THE FRA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN TIP WITH A FRAGMENT FALL, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED, BUT IT H... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THE SYSTEM WAS GETTING CONTINUOUS INTEGRATED ELECTROSURGICAL UNIT (IESU) FAULTS. THE CUSTOMER INFORME... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING CONTINUOUS IESU FAULTS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE COULD ... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH NEOBLADDER SURGICAL PROCEDURE, THE TIP OF THE CADIERE FORCEPS INSTRUMENT FELL INSIDE THE PATIENT'S ABDOMEN. THERE... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE CADIERE FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION COULD NOT REPRODUCE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. THE CADIERE FORCEPS INSTRUMENT WAS ANALYZED AND THE COMPLAINT REGARDING THE CLAMP ... |
Brand Name:DAVINCI XIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT A DA VINCI-ASSISTED PROSTATECTOMY PROCEDURE WAS CONVERTED TO A TRADITIONAL LAPAROSCOPIC PROCEDURE DUE TO BLEEDING THAT COULD NOT BE CONTROLLED. AS A RESU... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE INTRA-OPERATIVE COMPLICATION CANNOT BE DETERMINED. THERE IS NO REPORT THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. THIS COMPLAINT IS BEING REPORTED DUE TO T... |
Brand Name:DA VINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, SYSTEM GENERATED A NON-RECOVERABLE FAULT 297. PRIOR TO CALLING TECH SUPPORT THE CUSTOMER... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR 297 OCCURRED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC (ISI)TECHNICAL SUPPORT ENGINEER (TSE) WAS CONTACTED FOR TROUBLESHOOTING ASSISTANCE. TSE CHECKED THE LOGS THAT WERE SHOWING REPEATED N... |
Brand Name:SUREFORMDevice Problem: Failure to Form Staple; Failure to CutPatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CONVERSION LAP BAND TO SLEEVE PROCEDURE, THE SUREFORM 60 STAPLER INSTRUMENT FIRED A BLUE SUREFORM 60 RELOAD AND PUSHED THE STOMACH TISSUE.... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION HAS BEEN DEEMED PRODUCT RELATED. ISI REQUESTED THE BLUE SUREFORM 60 RELOAD USED DURING THIS EVENT TO BE RETURNED, BUT THE PRODUCT WAS DISCARDED BY THE CUSTOMER. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. INTUITIVE SU... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEMICOLECTOMY SURGICAL PROCEDURE, THERE WERE NON-RECOVERABLE ERRORS ON THE PATIENT SIDE CART (PSC). THE CUSTOMER CALLED IN D... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-RECOVERABLE ERRORS ON THE PATIENT SIDE CART (PSC), AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SIGMOID COLECTOMY SURGICAL PROCEDURE, THE TIP OF THE FORCE BIPOLAR INSTRUMENT BROKE OFF. THE TIP WAS RETRIEVED AND WAS INCLUDED WITH THE ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE TIP OF THE FORCE BIPOLAR INSTRUMENT BROKE OFF, AN INVESTIGATION IS PENDING TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FORCE BIPOLAR INSTRUMENT, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. A FOLLOW-... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ESOPHAGECTOMY TRANSTHORACIC ¿ CHEST ANASTOMOSIS SURGICAL PROCEDURE, THE BLACK CONDUCTOR WIRE INSULATION OF THE MARYLAND BIPOLAR FORC... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE CONDUCTOR WIRE INSULATION OF THE MARYLAND BIPOLAR FORCEPS WAS DAMAGED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYL... |
Brand Name:ENDOWRISTDevice Problem: Material SeparationPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT THE LONG BIPOLAR GRASPER (LBG) INSTRUMENT WAS BROKEN. THE BROKEN PIECE FELL INTO THE PATIENT¿S ANATOMY. THE CUS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE LONG BIPOLAR GRASPER (LBG) INSTRUMENT WAS BROKEN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE LBG INSTRUMENT WAS ANALYZE... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 4 WAS FAULTING. THE OPERATING ROOM (OR) STAFF DI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNIVERSAL SURGICAL MANIPULATOR (USM) 4 WAS FAULTING DURING THE PROCEDURE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURT... |
Brand Name:DAVINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE SYSTEM WAS GETTING REPEATED RECOVERABLE ERROR 32097 ON THE UNIVERSAL SURGICAL MANIPUL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED RECOVERABLE ERROR 32097, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ... |
Brand Name:DA VINCI XIDevice Problem: Visual Prompts will not ClearPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE OPERATION ROOM (OR) TECHNICIAN CONTACTED THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR 48200, AN INVESTIGATION IS IN PROGRESS. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED COMPLAINT. THE FSE WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED ... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITHOUT LYMPHADENECTOMY SURGICAL PROCEDURE, THE CUSTOMER CALLED AN INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING M-12 ERROR, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN ISI FIELD SERVICE ENGINEER (FSE) HAS BEEN DISPATCHED TO INVESTIGATE THE REPORTED EVENT. THE FSE REPRODUCED THE ISSUE AND REPLACED THE INTEGRATED ELECTROSURGICAL UNI... |
Brand Name:NONEDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT BLADE BROKE OFF AND FELL INSIDE THE PATIENT. THE FRAGMENT WAS RETRIEVED... | INTUITIVE SURGICAL, INC. (ISI) PERFORMED FOLLOW-UP AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: THE INSTRUMENT WAS REPORTEDLY INSPECTED PRIOR TO USE, AND NO ISSUES WERE NOTED. THE INSTRUMENT PERFORMED AS INTENDED UP UNTIL IT BROKE. THE INSTRUMENT DID NOT MAKE CONTACT WITH ANY ... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THE SURGICAL PROCEDURE, MEDIUM-LARGE CLIP APPLIER DID NOT CLOSE THE CLIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUIT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING UNABLE TO CLOSE CLIP, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED AND FOUND TO ... |
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