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Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In Patient; Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE TIP OF THE PERMANENT CAUTERY SPATULA (PCS) BROKE OFF AND FELL INSIDE THE ... | AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE PERMANENT CAUTERY SPATULA (PCS) TO PERFORM FAILURE ANALYSIS (FA). FA DID CONFIRM THE CUSTOMER REPORTED COMPLAINT AND FOUND THE PRIMARY FINDING OF A BROKEN SPATULA. THE INSTRUMENT WAS FOUND TO HAVE A ... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT A MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS NOT FIRING CORRECTLY. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. | A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. |
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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE JAWS OF THE MEDIUM-LARGE CLIP APPLIER CLOSED TIGHT AFTER APPLYING A CLIP AND WOULD NOT REOPEN... | A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE DEVICE RETURNED. HOWEVER, ISI HAS NOT RECEIVED THE PRODUCT INVOLVED WITH THE ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER R... |
Brand Name:ENDOWRISTDevice Problem: Entrapment of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, THE LONG BIPOLAR GRASPER INSTRUMENT WAS STICKING TO PATIENT'S TISSUE. THE PROCEDURE WAS COMPLET... | INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION.
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Brand Name:SINGLE-SITEDevice Problem: Unintended MovementPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE WRISTED NEEDLE DRIVER INSTRUMENT MOVED TO THE OPPOSITE DIRECTION. THERE WAS NO REPORT OF FRAGMENT(S) FA... | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. |
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 BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, ERROR 319 OCCURRED AGAINST UNIVERSAL SURGICAL MANIPULATOR (USM) 3. THE CUSTOMER STA... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE NOTICED THAT THE SYSTEM WAS IN A HARD FAULT STATE WITH ERROR 319. THE USM WAS COMPLETELY DISABLED AND UNABLE TO BE RECOVERED. THE FSE REPLACED THE USM TO RESOLVE THE REPO... |
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 SIGMOID COLECTOMY SURGICAL PROCEDURE, REPEATED ERRORS OCCURRED AGAINST UNIVERSAL SURGICAL MANIPULATOR 3 (USM). THE INTUITIVE SURG... | 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 REPLICATE THE REPORTED ISSUE AFTER TURNING THE SYSTEM ON. THE FSE REPLACED THE USM TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY ... |
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 UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THAT PRIOR TO DOCKING, A COUPLE OF NON RECOVERABLE FAULTS OCCURRED. PRIOR TO CALLI... | AN INTUITIVE FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND REPLACED THE ENDOSCOPE CONTROLLER (EC) AND THE FIBER OPTIC CABLE ASSEMBLY TO RESOLVE THE ISSUE. SYSTEM TESTED AND VERIFIED AS READY FOR USE. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. ANALYSIS IS IN PROGRESS. A FO... |
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 THYMECTOMY SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT WAS SEPARATED. THE FRAGMENT FELL INTO THE PATIENT¿S CAVITY AND WAS RETRI... | A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE HARMONIC ACE INSTRUMENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT METAL WIRE WAS LOOSE AND FELL INTO THE PATIENT'S STOMACH. THE WIRE WAS DIRECTLY IDENTIFIED A... | AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. |
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 PROSTATECTOMY SURGICAL PROCEDURE, THE FOREIGN OBJECT FELL INTO THE PATIENT¿S ABDOMINAL CAVITY DURING THE PORT PLACEMENT. THE CUSTOMER REMOVED ... | AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient 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 (VSE) INSTRUMENT WAS MOVING WHEN FIRING ENERGY. PRIOR TO CALLING IN, THE... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE WAS UNABLE TO REPRODUCE THE ISSUE. THE INITIAL REPORTER, ISI REPRESENTATIVE, BELIEVED THAT THE SURGEON DID NOT USE A PORT STABILIZER WITH THE VESSEL SEALER EXTEND (VSE) I... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT CONDUCTOR WIRE WAS LOOSE, BROKEN, OR DISCONNECTED. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIV... |
Brand Name:DAVINCI XIDevice Problem: Failure to Deliver EnergyPatient Problem: Burn(s)Event Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED HYSTERECTOMY, THERE WAS NO OUTPUT OF MONOPOLAR ENERGY. IN AN ATTEMPT TO RESOLVE THE ISSUE BEFORE CALLING THE TECHNICAL SUPPORT ENGINEER (TSE), THE CUSTOMER POWER-CYCLE... | A FIELD SERVICE ENGINEER (FSE) MADE A SITE VISIT TO EVALUATE THE SYSTEM AND WAS UNABLE TO REPRODUCE THE PROBLEM. THE SYSTEM WAS TESTED AND VERIFIED AS READY TO USE. A SYSTEM LOG REVIEW DID NOT REVEAL ANY SYSTEM ERRORS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FIELDS G5 AND G7 ARE NOT APPLICABLE. |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THE CUSTOMER REPORTED TO THE TECHNICAL SERVICE ENGINEER (TSE) ENCOUNTERING A REPEATED ERROR C-82 ERROR ON THE... | 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 INTEGRATED ELECTROSURGICAL UNIT (IESU). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE IESU; HOWEVER, FAILURE ANALYSIS HAS NOT COM... |
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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS NOT FUNCTIONING PROPERLY. THE PROCEDURE WAS COMPL... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE INSTRUMENT IS EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED. |
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 VESSEL SEALER EXTEND ((VSE) INSTRUMENT WAS UNABLE TO OPEN OR CLOSE. THE USER CONTINUED THE PROCEDURE USING AN... | ISI HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS IS STILL ONGOING. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. A FOLLOW-UP MDR WILL BE SUBMITTED POST FAILURE ANALYSIS EVALUATION. |
Brand Name:ENDOWRISTDevice Problem: Failure to SensePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE CURVED-TIP STAPLER 30 INSTRUMENT WAS ROTATING IMPROPERLY AND NOT ENGAGING. THE PROCEDURE WAS COMPLE... | AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RETURN MATERIAL AUTHORIZATION (RMA) HAS BEEN ISSUED 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 REPORTED ISSUE... |
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 LIVER RESECTION SURGICAL PROCEDURE, THE SYSTEM HAD REPEATED NON-RECOVERABLE ERROR ON THE UNIVERSAL SURGICAL MANIPULATOR (USM#1). ... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INVESTIGATE THE REPORTED EVENT FURTHER. THE FSE REPLACED THE USM, DISTAL SET UP JOINT (SUJ), PROXIMAL SET UP JOINT (SUJ), AND A WRIST FIBER CABLE TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS REA... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO START OF A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS NOT WORKING PROPERLY. THE PROCEDURE WA... | AN INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF FUNCTIONAL TEST FAILED-CLIP TEST ... |
Brand Name:ENDOWRIST SPDevice Problem: Unintended MovementPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT DELIVERING ENERGY. THE CUSTOMER REPLACED THE CAUTERY CA... | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE PROVIDED IMAGE SHOWS THE DISTAL TIP IS DISLODGED FROM ITS NORMA... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE PERMANENT CAUTERY SPATULA (PCS) WIRE WAS DAMAGED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. | INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT; HOWEVER, FAILURE ANALYSIS HAS NOT COMPLETED THEIR INVESTIGATION. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN FAILURE ANALYSIS HAS COMPLETED THEIR INVESTIGATION.
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Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA - UNILATERAL SURGICAL PROCEDURE, SURGEON COULDN'T ROLL THE PERMANENT CAUTERY HOOK FORWARD. THE PROCEDURE WAS COMPLETED ... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PERMANENT CAUTERY HOOK WAS ANALYZED AND NO PROBLEM WAS DETECTED. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND E... |
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 SEGMENTAL PANCREATECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS VERY STIFF. THE INSTRUMENT JAW WAS VERY DIF... | AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. |
Brand Name:DAVINCI XDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Cardiac ArrestEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE PATIENT WENT INTO CARDIORESPIRATORY ARREST. THIS OCCURRED AFTER THE DA VINCI SYSTEM WAS UNDOCKED A... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE POST-OPERATIVE COMPLICATION CANNOT BE DETERMINED. NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. FOR EVALUATION. BLANK MDR FIELDS: THE MISSING PATIENT INFORMATION IN SECTIONS A AND B WAS EITHER UNKNOWN, UNAVAILABLE, NOT PROVIDED, OR NOT APPLICABLE. T... |
Brand Name:SUREFORMDevice Problem: Insufficient InformationPatient Problem: Hemorrhage/BleedingEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ROUX-EN-Y PROCEDURE, THERE WAS UNEXPECTED BLEEDING FROM THE STAPLE LINE. THE PROCEDURE WAS COMPLETED AS PLANNED, BUT THE PATIENT REQUIRED A BLOOD TRANSFUSION.... | NO PRODUCT HAS BEEN RETURNED TO INTUITIVE SURGICAL, INC. (ISI) FOR EVALUATION. DUE TO INSUFFICIENT PROCEDURAL INFORMATION, FURTHER SYSTEM/INSTRUMENT LOG INVESTIGATION CANNOT BE PERFORMED. |
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 SIGMOID COLECTOMY SURGICAL PROCEDURE RECOVERABLE ERRORS OCCURRED. THE ERRORS OCCURRED WHEN TRYING TO DEPLOY FOR DOCKING. THE INTU... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. BASED ON THE FIELD EVALUATION, THIS REPORTED EVENT WAS CONFIRMED. THE ISI FSE CONTACTED THE INTUITIVE TECHNICAL SERVICE ENGINEER (TSE) FOR TROUBLESHOOTING. THE ISI FSE FOUND SEVE... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Hemorrhage/Bleeding; Unspecified Tissue InjuryEvent Description: IT WAS REPORTED IN A SOCIAL MEDIA POST, THAT AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THERE WAS BLEEDING FROM THE STAPLE LINE ON THE STOMACH. THE AMOUNT OF BLEEDING I... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED A PRODUCT FOR FAILURE ANALYSIS EVALUATION. THE LOGS WERE NOT AVAILABLE, SO THE PROCEDURE REVIEW DASHBOARD WAS USED TO COLLECT DATA ON THE INSTALLS. THE DASHBOARD SHOWED THE SUR... |
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 PARTIAL NEPHRECTOMY SURGICAL PROCEDURE, AN ERROR 319 OCCURRED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE INTUITIVE SURGICAL, ... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE ISSUE AND FOUND AN ERROR 319 IN THE ERROR LOG ON UNIVERSAL SURGICAL MANIPULATOR (USM) 4. THE FSE REPLACED USM 4 TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS NOT RECEIVED THE USM FOR EVALUATION.... |
Brand Name:DAVINCI XIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Hemorrhage/Bleeding; Sepsis; Respiratory FailureEvent Description: IT WAS REPORTED THAT THE PATIENT UNDERWENT A DA VINCI-ASSISTED BARIATRIC REVISION PROCEDURE. THE PATIENT EXPERIENCED POST-OPERATIVE LEAK ON THE G... | AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THE LEAK POST-BARIATRIC REVISION PROCEDURE. BASED ON THE INVESTIGATION, THERE IS NO INDICATION THAT THE DEVICE DIRECTLY CAUSED THE POST-OPERATIVE LEAK. NO DEVICE WAS RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF THE DA VINCI SYSTEM, INSTR... |
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 TOTAL GASTRECTOMY SURGICAL PROCEDURE, THE CLIP COULD NOT BE RELEASED FROM THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT. THE CUSTOMER USED... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FOR FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FAILED THE CLIP TEST DUE TO MISAPPLICATION OF THE CLIP. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. ... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED IN A SOCIAL MEDIA POST, THAT AFTER A DA VINCI-ASSISTED PROCEDURE, THERE WERE MALFORMED STAPLES AFTER USING A SUREFORM STAPLER WITH A WHITE RELOAD. AN ERROR MESSAGE WAS RECEIVED, TISSUE TO... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. AN RMA WAS NOT ISSUED FOR RETURN AS THE CUSTOMER REPORTED THE EVENT AFTER THE COMPLETION OF THE PROCEDURE; THEREFORE, FAILURE ANALYSIS CANNOT BE PERFORMED. THE FOLLOWING INVESTIGATIONS COULD NOT BE PERFORMED DUE TO INSUFFICI... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX WHICH REQUIRED CHEST TUBE PLACEMENT AND HOSPITALIZATION. THE TARGET NODULE ... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE PNEUMOTHORAX CANNOT BE DETERMINED. THERE WAS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. SYSTEM LOGS WERE NOT AVAILABLE FOR REVIEW. |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Cardiac Arrest; Cardiomyopathy; Stroke/CVAEvent Description: IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT CODED WHEN THE PHYSICIAN WAS NAVIGATING TOWARDS THE TARGET LESION AND BEFORE... | A SYSTEM LOG REVIEW CANNOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE. A REVIEW OF THE EVENT WAS PERFORMED BY AN INTUITIVE SURGICAL MEDICAL SAFETY OFFICER (MSO) WHO CONCLUDED THAT THE PATIENT SUFFERED A CARDIAC ARREST DURING THE NAVIGATION PORTION OF A ROBOTIC ASSISTED BRONCHOSCOPY AND WAS SUCCESSFULLY RESU... |
Brand Name:DAVINCI XIDevice Problem: No Device OutputPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE THAT ARM 3 WAS NOT REGISTERING STERILE ADAPTERS. THE SURGEON CONTINUED WITH THE PROCEDURE USING THREE ARMS. THERE W... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) CONFIRMED THAT THE ARM 3 DISCS DID NOT SPIN WHEN THE STERILE ADAPTER WAS ATTACHED. THE FSE DETERMINED THAT THERE WAS AN ISSUE WITH THE PRESENCE PINS AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE FSE TESTED THE SYSTEM AND VE... |
Brand Name:WECK VISTADevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Hemorrhage/Bleeding; Great Vessel PerforationEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED VENTRAL HERNIA REPAIR PROCEDURE, DURING PORT PLACEMENT, A BRANCH OF THE ABDOMINAL AOR... | THERE WAS NO REPORT OF ANY ISSUES WITH THE DA VINCI OR THIRD-PARTY PRODUCTS USED DURING THE INITIAL UNSUCCESSFUL CANNULA PLACEMENT ATTEMPT OR THE SECOND PLACEMENT WITH THE LONGER TROCAR. THE DA VINCI SYSTEM WAS NEVER DOCKED FOR THE SCHEDULED PROCEDURE; THEREFORE, THERE ARE NO SYSTEM LOGS AVAILABLE. A MEDICAL REVIEW WAS... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: Hemorrhage/Bleeding; Unspecified Tissue InjuryEvent Description: IT WAS REPORTED IN A SOCIAL MEDIA POST, THAT AFTER A DA VINCI-ASSISTED SLEEVE GASTRECTOMY PROCEDURE, THERE WAS BLEEDING FROM THE STAPLE LINE ON THE STOMACH. THE AMOUNT OF BLEEDING I... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. AN RMA WAS NOT ISSUED FOR RETURN AS THE CUSTOMER REPORTED THE EVENT AFTER THE COMPLETION OF THE PROCEDURE; THEREFORE, FAILURE ANALYSIS CANNOT BE PERFORMED. THE LOGS SHOW THE SUREFORM 60 STAPLER (PRODUCT NUMBER: 480460-09, LO... |
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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS NOT CLIPPING. THE PROCEDURE WA... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND WITH ONE GRIP BENT. THE DAMAGE WAS FOUND NEAR THE TOP OF THE CLIP GROOVE, CAUSING AN OFFSET AT THE TIPS. AS A RESULT, THE CLIP COU... |
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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT'S JAWS WOULD NOT CLOSE. THE PROCEDURE WAS COMPLETED WITH... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS ANALYZED. THE INSTRUMENT WAS FOUND TO HAVE A BENT GRIP AND THE TIP DID NOT ALIGN WITH THE OTHER GRIP. THE COMPLAINT WAS CONFIRMED BASED ON FAILURE ANALYSIS. |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING DA VINCI ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE DAMAGED CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT TO PERFORM ANALYSIS. THE INSTRUMENT WAS ANALYZED. THE INSTRUMENT WAS FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL IDLER PULLEY. THE FRAYED CABLE STRANDS STUCK OUT AT THE WRIST. ADDITIONALLY, THE INSTRUMENT WAS FOUND TO HAVE DAMA... |
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 EXTRAPERITONEAL WITH LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE, ERROR C-34 OCCURRED. THE INTUITIVE SURGICAL, INC. ... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE ISSUE AND REPLACED THE VIO INTEGRATED ELECTROSURGICAL GENERATOR UNIT (IESU) TO RESOLVE THE ISSUE. SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE IESU, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. THEREFOR... |
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 CUSTOMER CALLED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) AND RE... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE ISI FSE REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM). THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (IS... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: THE PRODUCT WAS RETURNED AS A DISCREPANT RETURN MATERIAL AUTHORIZATION (RMA). THERE WAS NO ISSUE REPORTED FOR THIS PRODUCT. | INTUITIVE SURGICAL, INC. (ISI) RECEIVED A FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT AS DISCREPANT RETURN MATERIAL AUTHORIZATION (RMA). THERE WAS NO ALLEGED MALFUNCTION REPORTED AGAINST THIS PRODUCT. THE FBF INSTRUMENT WAS ANALYZED. THE INSTRUMENT WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING ON THE BIPOLAR YAW PU... |
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 CHOLECYSTECTOMY SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS UNABLE TO APPLY THE CLIP. THE CABLE WAS NOTED TO ... | THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT HAS BEEN EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM. FA WAS ABLE TO CONFIRM THE REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A CRACKED INPUT. INPUT DISK #7 WAS FOUND CRACKED INSIDE THE HOUSING. AS A RESULT, THE GRIP CABLE UNRAVELED AND BECAME LOOSE AT THE DISTAL. THE... |
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 SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT DOES NOT WORK, BUT STILL HAS SOME LIFE LEFT. THE PROCEDURE WAS ... | 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 A BROKEN CONDUCTOR WIRE ON THE PROXIMAL END. THE LOCATION OF THE BREAK WAS NEAR THE MAIN TUBE-ROLL GEAR JUNCTION. THE INSTRUMENT FAILED THE ELECTRICAL CONT... |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAD A CRACKED INSULATION. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. | INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/OR IF ADDITIONAL INFORMATION IS RECEIVED. |
Brand Name:ENDOWRISTDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE FORCE BIPOLAR INSTRUMENT CONDUCTOR WIRE WAS LOOSE, BROKEN, OR DISCONNECTED. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. | AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. |
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 MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, UNIVERSAL SURGICAL MANIPULATOR (USM) 4 KEPT FAULTING. PRIOR TO CALLING INTUITIVE SURGI... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. THE FSE REPLACED UNIVERSAL SURGICAL MANIPULATOR (USM) 4 TO RESOLVE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID NOT RECEIVE A DA VINCI PRODUCT... |
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 INCISIONAL HERNIA SURGICAL PROCEDURE, THE SYSTEM WAS GETTING REPEATED NON-RECOVERABLE ERROR 281. THE ISSUE STARTED WITH A BROKEN ... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO FURTHER INVESTIGATE THE REPORTED EVENT. A SYSTEM LOG REVIEW WAS PERFORMED, AND IT WAS DETERMINED THAT THE ISSUE WAS LIKELY RELATED TO REMOTE ARM CONTROLLER (RAC) 1 OR THE LEFT MASTER TOOL MANIPULATOR (MTM). THE FSE DIS... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TENACULUM FORCEPS INSTRUMENT HAD BROKEN WIRES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. | INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TENACULUM FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN DISTAL PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS MISSING FROM THE CLEVIS. WHEN PITCH CABLE BREAKAGE OCCURS, THE INSTR... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA TAR SURGICAL PROCEDURE THAT THE SURGEON WAS UNABLE TO USE MONOPOLAR COAGULATION. THE LOGS SHOWED REPEATED C-34 ERRORS. THE PRO... | INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CONFIRMED THE REPORTED ERBE ERRORS. THE ISI FSE TURNED THE ERBE ON/OFF MULTIPLE TIMES WITH THE SAME RESULTS OF C-34 AND C-00 ERRORS. THE ISI FSE TRIED MULTIPLE OUTLETS AND DIFFERENT POWER CORDS WITH NO CHANGE. THE ERBE WAS REPLACED TO RESOLVE ... |
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 LIVER RESECTION SURGICAL PROCEDURE, THE BIPOLAR ENERGY WAS GIVING AN ERROR. THE E-100 GENERATOR HAD A FLASHING LED AMBER LIGHT WH... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS NOT ABLE TO REPRODUCE THE ISSUE BUT REPLACED THE E-100 GENERATOR. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI DID RECEIVE THE E-100 GENERATOR TO PERFORM FAILURE ANALYSIS (FA). FA WAS NOT ABLE TO REPRODUCE THE CUSTOMER REPORTED COMPLAINT. AF... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT WAS NOT CLIPPING OR CLOSING PROPERLY. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY. | FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER-REPORTED COMPLAINT THAT THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT FAILED THE CLIP TEST DUE TO MISAPPLICATION OF THE CLIP. THE MEDIUM-LARGE CLIP APPLIER WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TESTS. HOWEVER, THE INSTRUME... |
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 DISTAL PANCREATECTOMY SURGICAL PROCEDURE, A BROKEN CABLE WAS NOTED ON A FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE PROCEDURE WA... | 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 A BROKEN GRIP CABLE AT THE DISTAL END. THE INSTRUMENT WAS ALSO FOUND TO HAVE A LOOSE GRIP CABLE AT THE DISTAL END. THE INSTRUMENT HAS A BROKEN GRIP CABLE A... |
Brand Name:ENDOWRISTDevice Problem: Break; Difficult to RemovePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE PART BETWEEN THE WRIST AND THE SHAFT OF THE TIP-UP FENESTRATED GRASPER (TUFG) INSTRUME... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE TIP-UP FENESTRATED GRASPER (TUFG) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE MAIN TUBE BROKEN. A PIECE MEASURING PROXIMATELY 0.201¿ X 0.145¿ WAS BROKEN OFF THE INSTRUMENT. THE INSTRUMENT HOUSING WAS REMOVED, AND THE CLAMPI... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT JAW BROKE FROM THE INSTRUMENT SHAFT. THE PROCEDURE WAS COMPLETED AS PLANNE... | AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED; HOWEVER, ISI HAS NOT RECEIVED THE RMA TO CONFIRM/IDENTIFY ANY REPORTABLE FAILURE MODE(S). ISI HAS MADE SEVERAL ATTEMPTS TO OBTAIN THE RMA WITH NO SUCCESS.
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Brand Name:ENDOWRIST SPDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING THE MARYLAND BIPOLAR FORCEPS HAD A BROKEN WIRE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. | 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 REPORTED ISSUE. |
Brand Name:ENDOWRISTDevice Problem: Insufficient InformationPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH FORCE BIPOLAR INSTRUMENT. NO FRAGMENT FELL INTO THE PATIENT. A BACKUP DA VINCI INSTRUMENT OF THE SAME KIND WAS USED. THE PROCEDURE WAS COMPL... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FORCE BIPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP TIP. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS SURGICAL PROCEDURE, THE LARGE SUTURE CUT NEEDLE DRIVER INSTRUMENT HAD BROKEN AND EXPOSED CABLE. THE PROCEDURE WAS COMPLETE... | AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RETURN MATERIAL AUTHORIZATION (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 REP... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INCISIONAL HERNIA SURGICAL PROCEDURE, THE LARGE SUTURECUT NEEDLE DRIVER INSTRUMENT WIRE BROKE AND WOULD NOT WORK. THE PROCEDURE WAS COMPL... | AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RETURN MATERIAL AUTHORIZATION (RMA) HAD BEEN ISSUED REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED; HOWEVER, ISI DID NOT RECEIVE THE RMA TO CONFIRM/IDENTIFY THE FAILURE MODE. ADDITIONAL INFORMATION IS BEING GATHERED... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A ASSISTED DA-VINCI SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. FOLL... | INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE SMALL GRASPING RETRACTOR INSTRUMENT AND HAS BEEN EVALUATED BY THE FAILURE ANALYSIS TEAM. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE A BROKEN DISTAL PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THA... |
Brand Name:SINGLE-SITEDevice Problem: Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SUBTOTAL GASTRECTOMY SURGICAL PROCEDURE, THE WRISTED NEEDLE DRIVER (WND) HAD A BROKEN WIRE. NO FRAGMENT FELL INSIDE THE PATIENT. T... | AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MEGA SUTURE CUT NEEDLE DRIVER HAD A WIRE ON THE JAW THAT SNAPPED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. | A RETURN MATERIAL AUTHORIZATION (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 REPORTED ISSUE. |
Brand Name:NONEDevice Problem: No Apparent Adverse EventPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: THE SP INSTRUMENT SHEATH WAS AN INCIDENTAL RETURN. THERE WAS NO ISSUE REPORTED FOR THIS PRODUCT. | INTUITIVE SURGICAL, INC. (ISI) RECEIVED A SP INSTRUMENT SHEATH ACCESSORY AS AN DISCREPANT RETURN MATERIAL AUTHORIZATION (RMA). THERE WAS NO ALLEGED MALFUNCTION REPORTED AGAINST THIS PRODUCT. THE COEXTRUSION COMPONENT OF THE SHEATH WAS DISLODGED AND AS A RESULT WAS STUCK ON FENESTRATED BIPOLAR FORCEPS. THERE WAS NO COMP... |
Brand Name:ENDOWRISTDevice Problem: FracturePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MYOMECTOMY SURGICAL PROCEDURE, THE MEGA NEEDLE DRIVER INSTRUMENT CABLE WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. INTUITIVE SURGICAL... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MEGA NEEDLE DRIVER INSTRUMENT FOR FAILURE ANALYSIS. THE MEGA NEEDLE DRIVER INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN PITCH CABLE AT THE DISTAL END. THE BROKEN CABLE SEGMENT THAT CONTAINS THE CRIMP WAS STILL INSTALLED IN THE CLEVIS. WHEN PITCH CABLE BREAKAGE OCCURS, T... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BENIGN TONGUE BASE RESECTION SURGICAL PROCEDURE, THE PERMANENT CAUTERY SPATULA (PCS) SLEEVE WAS BROKEN. THE CUSTOMER USE... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PERMANENT CAUTERY SPATULA (PCS) INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN/ CERAMIC SLEEVE. BROKEN PIECE IS MISSING AS A RESULT OF BREAKAGE. SIZE OF MISSING PIECE IS APPROXIMATELY 0.044¿ X 0.067¿. THE COMPLAINT WAS CO... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD A BROKEN TIP. THERE WAS NO REPORTED INJURY. | AN RMA WAS ISSUED TO EVALUATE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. |
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 SURGEON WAS NOT ABLE TO CLOSE THE JAWS AND WAS NOT ABLE TO FIRE THE CLIP. THE BED SIDE ASSISTANT REMOVED THE ... | A RETURN MATERIAL AUTHORIZATION (RMA) HAD BEEN ISSUED REQUESTING TO HAVE THE ISI DEVICE RETURNED; HOWEVER, ISI DID NOT RECEIVE THE RMA TO CONFIRM/IDENTIFY THE FAILURE MODE. ADDITIONAL INFORMATION IS BEING GATHERED TO DETERMINE THE CONTRIBUTION OF THE DEVICE TO THE CUSTOMER REPORTED ISSUE. IMAGE REVIEW: THE REVIEW OF 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 SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE CUSTOMER CONTACTED SUPPORT REPORTING ERRORS ON ARM 4. THE CUSTOMER HAD RESTARTED WITH ... | AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) WAS ABLE TO REPRODUCE THE REPORTED COMPLAINT AND REPLACED THE UNIVERSAL SURGICAL MANIPULATOR (USM) TO RESOLVE THE ISSUE. THE SYSTEM WAS TESTED AND VERIFIED AS READY FOR USE. ISI HAS RECEIVED THE USM, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. THEREFOR... |
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