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Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM LONG BIPOLAR GRASPER HAD BROKEN WIRES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE 8MM LONG BIPOLAR GRASPER HAD BROKEN WIRES, 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. INTUITIVE HAS RECEIVED THE PART ASSOCIATED... |
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 PERMANENT CAUTERY HOOK (PCH) HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE S... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING 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 PERMANENT CAUTERY HOOK INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROK... |
Brand Name:NONEDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROCEDURE, THE FORCEPS GASKET WAS WARPED ON THE HARMONIC ACE INSTRUMENT. PROCEDURE WAS COMPLETED WITH NO PATIENT HARM. | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING GASKET WARPING ON THE HARMONIC ACE INSTRUMENT, 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 A... |
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 SURGEON WAS UNABLE TO CONTROL OF ARM 1 AND ARM 2 ON THE PATIENT SIDE CART (PSC). SURGEON STILL HA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SURGEON WAS UNABLE TO CONTROL OF ARM 1 AND ARM 2 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 S... |
Brand Name:ENDOWRISTDevice Problem: Failure to Deliver EnergyPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A VESSEL SEALER EXTEND INSTRUMENT HAD EXPOSED WIRES, SMOKED AND WAS NOT SEALING. THE PROCEDURE WAS COMPLETED AS PL... | THIS REPORT IS BEING SUBMITTED TO ADD FIELD ACTION INFORMATION. Manufacturer Narrative: BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SMOKING AND ARCING FROM THE VESSEL SEALER EXTEND INSTRUMENT, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO EVALUATE ... |
Brand Name:ENDOWRISTDevice Problem: Break; Failure to Deliver Energy; MeltedPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED ENDOMETRIOSIS RESECTION SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT WOULD NOT CAUTERIZE OR ENE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ENERGY ACTIVATION FAILURE WITH DAMAGED 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 INSTRUME... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Cardiac ArrestEvent Description: IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT CODED. THE PATIENT HAD BEEN HOSPITALIZED FOR ONE WEEK PRIOR TO THE PROCEDURE. THE PHYSICIAN STATED HE WA... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED EVENT CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A SYSTEM LOG REVIEW COULD NOT BE PERFORMED BECAUSE THE SYSTEM LOGS ARE NOT AVAILABLE. REVIEW OF THE CASE VIDEO RECEIVED FR... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED DISTAL PANCREATECTOMY SURGICAL PROCEDURE, THE JAWS OF THE FORCE BIPOLAR INSTRUMENT WERE OBSERVED TO BE MOVING ON THEIR OWN AND WITHOUT ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE JAWS OF A FORCE BIPOLAR INSTRUMENT MOVING ON THEIR OWN, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT, BUT FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. A FOLLOW-U... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED VENTRAL HERNIA IPOM SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT TIPS MOVED UP AND DOWN INSTEAD OF LEFT AND RIGHT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A NON-INTUITIVE MOTION ISSUE, 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 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 CUSTOMER INFORMED THE TECHNICAL SUPPORT ENGINEER THAT THE ARM FAULTED MULTIPLE TIMES ON T... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR ON ARM 1 OF THE PATIENT SIDE CART PSC, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. A FIELD SERVICE ENGINEER FSE WAS DISPATCH ON SITE TO INVESTIGATE THE REPORTED PROBLEM. THE FSE REPLACED THE UNIVERSAL SURGICAL MANIPUL... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL CYSTECTOMY WITH ILEAL CONDUIT SURGICAL PROCEDURE, A WIRE OF THE FENESTRATED BIPOLAR FORCEPS (FBF) WAS DAMAGED. THE CUSTOMER REPLA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING FBF INSTRUMENT CONDUCTOR WIRE DAMAGE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVE THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FBF INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A B... |
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 SURGICAL PROCEDURE, THE CUSTOMER FACED ERROR C-38 ON ERBE GENERATOR. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (T... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING MONOPOLAR ENERGY ISSUE, 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 ISI FSE R... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of Device; Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A FORCE BIPOLAR INSTRUMENT HAD A RECOGNITION ISSUE. THE PROCEDURE WAS COMPLETED... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE RECOGNITION ISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FORCE BIPOLAR INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) ... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT INSTALLED WITH BLUE RELOAD WAS USED AND INSPECTION AFTER STAPLI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING STAPLING ISSUES, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TWO BLUE STAPLER RELOADS INVOLVED WITH THIS COMPLAINT AND DEVICE EVALUATION WERE COMPLETED. THE REPORTED EVENT WAS NOT ... |
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 MYOMECTOMY SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THAT THE FORCE BIPOLAR INSTRUMENT'S WRIST WAS BROKEN, AND THE INSTRUMENT WOULD N... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE FORCE BIPOLAR INSTRUMENT'S WRIST WAS BROKEN, AND THE INSTRUMENT WOULD NOT GRIP PROPERLY, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE FORCE BIPOLAR INSTRUMENT FOR EVAL... |
Brand Name:NONEDevice Problem: Physical Resistance/StickingPatient 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 30 DEGREE ENDOSCOPE PLUS HAD NO MOVEMENT. THE PROCEDURE WAS COMPLETED WITH... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE 30 DEGREE ENDOSCOPE PLUS HAD NO 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 ANALYSIS. THE 30 DEGREE ENDOSCOPE PLUS INSTRUMENT WAS... |
Brand Name:ENDOWRISTDevice Problem: Entrapment of Device; Failure to CutPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED NEPHRECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT DID NOT CUT AND WOULD GET STUCK INTO TISSUE.... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING DID NOT CUT AND WOULD GET STUCK, 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... |
Brand Name:SUREFORMDevice Problem: Failure to Form StaplePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY SURGICAL PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT INSTALLED WITH BLUE RELOAD WAS USED AND INSPECTION AFTER STAPLI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING STAPLING ISSUES, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE TWO BLUE STAPLER RELOADS INVOLVED WITH THIS COMPLAINT AND DEVICE EVALUATION WERE COMPLETED. THE REPORTED EVENT WAS 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 INGUINAL HERNIA PROCEDURE ON (B)(6) 2018 . ON (B)(6) 2022, THE PATIENT UNDERWENT A SECOND SURGICAL PROCEDURE IN A DIFFERENT HOS... | BASED ON INFORMATION PROVIDED, THE ROOT CAUSE FOR THE REPORTED EVENT IS NOT DETERMINED. THERE IS INSUFFICIENT INFORMATION REGARDING THE CIRCUMSTANCES REGARDING THE PROCEDURE FOUR YEARS LATER, OR THE HOSPITAL IT OCCURRED IN. INTUITIVE SURGICAL, INC (ISI) HAS NOT RECEIVED INFORMATION REGARDING DISPOSITION OF THE RETRIEVE... |
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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD A FRAYED CABLE. NO CONDUCTOR WIRE ISSUE WAS ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD A FRAYED 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 MARYLAND BIPOLAR FORCEP... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or Close; Patient Device Interaction ProblemPatient 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 JAWS DID NOT CLOSE CORRECTLY, R... | BASED ON THE CLAIM AGAINST THE MEDIUM-LARGE CLIP APPLIER BY THE CUSTOMER NOTING THE INSTRUMENT'S JAWS DID NOT CLOSE CORRECTLY, RESULTING IN THE INABILITY TO APPLY CLIP AS INTENDED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT... |
Brand Name:SUREFORMDevice Problem: Misfire; Failure to FirePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE SUREFORM 60 STAPLER WITH A BLUE RELOAD HAD A PARTIAL FIRE. THERE WERE MULTIPLE PAUSES FOR COMPRESSION AND THE... | ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING SECTIONS: D9, G2, G3, G6, H2, H3, ANNEX B, C, D AND SECTIONS H10/H11. INTUITIVE HAS RECEIVED THE PART ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. STAPLER, SUREFORM 60 PN 480460-09; LN L10230214 WAS EVALUATED. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED... |
Brand Name:ENDOWRISTDevice Problem: BreakPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY, THE FORCE BIPOLAR INSTRUMENT'S JAWS WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY NOR DELAY. INTUITIVE SURGICAL, IN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A BROKEN JAW, 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 DEVICE TO THE ... |
Brand Name:SUREFORMDevice Problem: Failure to Form Staple; Failure to FirePatient Problem: Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not AvailableEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PULMONARY LOBECTOMY PROCEDURE, THE SUREFORM 45 STAPLER INSTRUMENT FAILED TO ENGAGE AFTER... | 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. AN ADVANCED REVIEW OF THE DEVICE LOGS WAS CONDUCTED BY... |
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 THAT ERROR 23020 OCCURRED ON PATIENT SIDE MANIPULATOR (PSM) 1. THE CUSTOMER ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT ERROR 23020 OCCURRED ON PATIENT SIDE MANIPULATOR (PSM) 1, 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 INVESTI... |
Brand Name:ENDOWRISTDevice Problem: Entrapment of Device; Failure to CutPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WOULD NOT CUT WELL ENOUGH AND WAS STUCK. T... | 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 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 CUSTOME... |
Brand Name:DAVINCI XIDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY-BENIGN SURGICAL PROCEDURE, CUSTOMER REPORTED THE DRAPE IS STUCK ON THE ARM. THE CUSTOMER HAD TO FINISH THE CAS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING MANIPULATOR PROBLEM 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 ISI FSE REPLA... |
Brand Name:DAVINCI 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 CUSTOMER WAS UNABLE TO STEER THE ARMS WITH THE LEFT MASTER TOOL MANIPULATOR (MTM) FROM THE SURGEON SIDE ... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE MASTER TOOL MANIPULATOR (MTM) INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATION WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. HOWEVER, THE ERROR COULD BE CONFIRMED AS HAVING OCCURRED VIA FIELD ERROR LOGS. VISUAL INSPECTION WAS PERF... |
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 GASTROSTOMY SURGICAL PROCEDURE, THE UNIVERSAL SURGICAL MANIPULATOR (USM) 2 WAS MOVING BY ITSELF. THE CUSTOMER RECEIVED PHONE ASSISTANC... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER AN ISSUE WITH USM ARM MOVEMENT, 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 ANALY... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SURGEON CALLED AN INTUITIVE SURGICAL, INC. ISI TECHNICAL SUPPORT ENGINEER (TSE) AND REPORTED A C-... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING C-34 ERROR, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. ISI FIELD SERVICE ENGINEER FSE HAS BEEN DISPATCHED TO INVESTIGATE THE REPORTED EVENT. THE ISI FSE REPLACED THE INTEGRATED ELECTROSURGICAL U... |
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 DISTAL GASTRECTOMY SURGICAL PROCEDURE, THE CUSTOMER WAS NOT ABLE TO APPLY A CLIP AS THERE WAS A WIRE COMING OUT AT THE INSTRUMENT TIP... | BASED ON THE CLAIM AGAINST THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT BY THE CUSTOMER NOTING THE INSTRUMENT EXHIBITED A CLIPPING 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 MEDIUM-LARGE ... |
Brand Name:ENDOWRISTDevice Problem: Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT THE SMALL GRASPING RETRACTOR INSTRUMENT HAD A BROKEN CABLE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITION... | 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 SMALL GRASPING RETRACTOR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A ... |
Brand Name:DAVINCI XDevice Problem: Insufficient InformationPatient Problem: Cardiac Arrest; Hemorrhage/Bleeding; Hypovolemic ShockEvent Description: INTUITIVE SURGICAL, INC. (ISI) RECEIVED NOTIFICATION OF A NEWS ARTICLE THAT WAS PUBLISHED ON A POLISH MAGAZINE WEBSITE. THE STORY DOCUMENTS INFORMATION FROM THE FAMILY OF... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE PATIENT¿S PERI-OPERATIVE COMPLICATIONS AND ULTIMATE DEMISE CANNOT BE DETERMINED. A STATEMENT PROVIDED BY THE SITE¿S MEMBERS OF THE BOARD DOCUMENTS, ¿THE HOSPITAL EMPHASIZES THAT THE PATIENT'S UNFAVORABLE COURSE OF TREATMENT WAS NOT RELATED TO THE PROCEDURE PERFORMED W... |
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 ADRENALECTOMY SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR INSTRUMENT'S WIRE BROKE WHILE PACKING TISSUE AND WAS REMOVED WITHOUT ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING WIRE BROKE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE SMALL GRASPING RETRACTOR INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVES... |
Brand Name:ENDOWRISTDevice Problem: Component Missing; Failure to CutPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED THYMECTOMY PROCEDURE, THE VESSEL SEALER EXTEND INSTRUMENT HAD A CUTTING ISSUE. IT WOULD SEAL WELL BUT COULD NOT CUT AFTER SEAL... | BASED ON THE SEALING AND CUTTING ISSUE REPORTED BY THE CUSTOMER, 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 VESSEL SEALER EXTEND VSE INSTRUMENT WAS ANALYZED AND FOUND FAILURE ANALYSIS INVESTIG... |
Brand Name:ENDOWRISTDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SURGICAL PROCEDURE, THE TIP UP FENESTRATED GRASPER INSTRUMENT'S DISTAL END BECAME MISALIGNED. THE PROCEDURE WAS COMPLETED WI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING GRIP FAILURE OR INSUFFICIENT, 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 TIP UP FENESTRATED GRASPER WAS ANALYZED AND FOUND THE PRI... |
Brand Name:NONEDevice Problem: Defective ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEPATECTOMY SURGICAL PROCEDURE, THE CUSTOMER TEAM FOUND A DEGRADATION AND A LOOSENING OF THE INSULATING PLASTIC ON THE HARMONIC ACE INSTRUME... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE DEGRADATION AND A LOOSENING OF THE INSULATING PLASTIC ON THE JAWS OF THE HARMONIC ACE INSTRUMENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE HARMONIC ACE INSTRUMENT INVOLVED W... |
Brand Name:NONEDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LEFT HEPATECTOMY SURGICAL PROCEDURE, WHILE SECTIONING THE LIVER SLICE, THE CUSTOMER TEAM FOUND A DEGRADATION AND A LOOSENING... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING LOOSENING OF THE INSULATING PLASTIC OF THE ROBOTIC HARMONIC ACE JAWS, 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... |
Brand Name:ENDOWRISTDevice Problem: Material SeparationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED DURING CENTRAL PROCESSING, THAT ONE SIDE OF THE TIP OF A TIP-UP FENESTRATED GRASPER INSTRUMENT, BROKE OFF DURING REPROCESSING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. I... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BREAKAGE ON THE INSTRUMENT, 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 TIP-UP FENESTRATED BIPOLAR INSTRUMENT WAS ANALYZED AND FO... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED HYSTERECTOMY MALIGNANT SURGICAL PROCEDURE, THE LARGE NEEDLE DRIVER WAS NOT MOVING AS THE SURGEON INTENDED. THE PROCEDURE WAS COMPLETED ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE ARM NOT MOVING AS THE SURGEON INTENDED, 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 LARGE NEEDLE DRIVER INSTRUMENT WAS ANALYZED... |
Brand Name:DAVINCI XIDevice Problem: FirePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE MONOPOLAR ENERGY CABLE CAUGHT ON FIRE AT BOTH ENDS OF THE CONNECTION. INTUITIVE SURGICA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING FIRE AT BOTH ENDS, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. AN ISI TECHNICAL SUPPORT ADVISED THE CUSTOMER THAT MONOPOLAR ENERGY CABLES CAN ONLY BE USED 20-25 TIMES. AN ... |
Brand Name:DAVINCI XIDevice Problem: No Device Output; 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 UNIVERSAL SIDE MANIPULATOR (USM) EXHIBITED INSTRUMENT ENGAGEMENT FA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE PERSISTENT USM 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. DURING FIELD... |
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 MARYLAND BIPOLAR FORCEPS INSTRUMENT WIRE HAD DAMAGED INSULATION. THERE WAS NO REPORT OF PATIENT INJURY.Event Description: REFER ... | BASED ON THE CLAIM AGAINST THE PRODUCT NOTING INSULATION DAMAGE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN 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 DEVI... |
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 CHOLECYSTECTOMY SURGICAL PROCEDURE THAT A LARGE CLIP APPLIER INSTRUMENT WAS STUCK ON ARM 3 OF THE PATIENT SIDE CART (PSC). THE INTUITI... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE REPORTED COMPLAINT WAS CONFIRMED VIA THE ERROR LOGS,. THE UNIVERSAL SURGICAL MANIPULATOR (USM) WAS TESTED ON THE SYSTEM USING THE FOLLOWING INSTRUMENTS: FENESTRATED BIPOLAR FORCEPS, CAMERA AND, LARGE NEEDLE DRIVER. THE UNIT WAS ... |
Brand Name:ENDOWRISTDevice Problem: Failure to Deliver EnergyPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) WAS STUCK ON THE ARM WITH THE BLADE EXPOSED. THE CUSTOMER STATED, THA... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING STUCK ON THE ARM WITH THE BLADE EXPOSED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER STATED, THAT THEY WERE ABLE TO REMOVE THE INSTRUMENT. THERE WAS MINOR BLE... |
Brand Name:ENDOWRISTDevice Problem: ArcingPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, A CLIP APPLIER INSTRUMENT WAS FOUND TO HAVE A BURN MARK. THE PERMANENT CAUTERY HOOK INSTRUMENT USED IN THE MOST RECENT PROCEDURE IS MOST LIKELY TO HAVE CAUSED THE BURN MA... | INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL/UPDATED INFORMATION REGARDING THE REPORTED EVENT: NO ARCING WAS OBSERVED IN THE PROCEDURE. THE PERMANENT CAUTERY HOOK IS NOT AVAILABLE FOR RETURN. THERE WAS NO TISSUE DAMAGE. THERE WERE NO UNPLANNED SURGICAL TASKS... |
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 SIMPLE PROSTATECTOMY SURGICAL PROCEDURE, AN ERROR 23008 OCCURRED ON THE SYSTEM. THE CUSTOMER RECOVERED THE FAULT, BUT THE ERROR R... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN ERROR MESSAGE/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. THE FSE CONFIR... |
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 FENESTRATED BIPOLAR FORCEPS INSTRUMENT'S JAWS DID NOT CONNECT AND WOULD NOT GRAB TISSUE. THE PROCEDURE WAS CO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT A FENESTRATED BIPOLAR FORCEPS INSTRUMENT'S MISALIGNED JAWS AND WOULD NOT GRAB TISSUE, 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. T... |
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 PROSTATECTOMY SURGICAL PROCEDURE, THE INSTRUMENT SEALED, BUT WAS UNABLE TO CUT. THE BLADE BECAME LODGED IN THE JAWS AND THE JAWS WOU... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSTRUMENT SEALED BUT WAS UNABLE TO CUT, AN INVESTIGATION IS PENDING TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA WAS ISSUED TO THE CUSTOMER REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION IS BEING G... |
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, AN INTEGRATED ELECTROSURGICAL UNIT (IESU) ERROR C-34 OCCURRED PERSISTENTLY WHEN THE CUSTOMER WAS ATTEMPTING T... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING IESU ERROR C-34 OCCURRED, 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 ISI FSE CO... |
Brand Name:ENDOWRISTDevice Problem: Firing ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE CLIP APPLIER INSTRUMENT FAILED TO FIRE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. I... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE CLIP APPLIER INSTRUMENT FAILED TO FIRE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. FAILURE ANALYSIS OF THE CLIP APPLIER INSTRUMENT FOUND THE PRIMARY FAILURE OF FAILED CLIP TEST TO BE RELATED TO THE CUSTOMER REPORTED COM... |
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 NEPHROURETERECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED THAT UNIVERSAL SURGICAL MANIPULATOR (USM)3 HAD RECOVERABLE FAULTS. T... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DISTAL SET UP JOINT (SUJ) UNIT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE LOGS WERE EXAMINED AND ERRORS 32101 AND 3209 WERE SEEN NUMEROUS TIMES. THE UNIT WAS PUT ON SYSTE... |
Brand Name:ENDOWRISTDevice Problem: Difficult to Open or ClosePatient Problem: Unspecified Tissue InjuryEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARTIAL NEPHRECTOMY PROCEDURE, THERE WAS TISSUE ENTRAPMENT WITH THE FORCE BIPOLAR INSTRUMENT. THE ISSUE OCCURRED WHILE THE FORCE BIPOLAR INSTRUMENT W... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THE DEVICE INVOLVED WITH THIS EVENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. REVIEW OF THE SYSTEM LOG WAS COMPLETED, AND NO RELA... |
Brand Name:ENDOWRISTDevice Problem: Difficult to RemovePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING DA VINCI-ASSISTED RIGHT-SIDE HEMICOLECTOMY, THE VESSEL SEALER EXTEND INSTRUMENT GOT STUCK ON TISSUE AND WOULD NOT RELEASE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. I... | 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 PRODUCT TO PERFORM FAILURE ANALYSIS. THE VESSEL SEALER EXTEND WAS ANALYZED AND FOUND NO FAILURES. THE INSTRUMENT WAS PLACED AND DRIV... |
Brand Name:DA VINCIDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF. THE FRAGMENT FELL INSIDE THE PATIENT¿S CAVITY AND WAS RETRIEVED DURI... | INTUITIVE SURGICAL, INC. (ISI) HA NOT RECEIVED THE HARMONIC ACE INSTRUMENT FOR FAILURE ANALYSIS EVALUATION. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE TIP OF THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE. THE FRAGMENT WAS RETRI... |
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 WEDGE RESECTION SURGICAL PROCEDURE, THE CUSTOMER REPORTED ARM 4 JERKED BACK AFTER LATERAL MOVEMENT. IT WAS NOTED THAT NO... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ARM 4 JERKED BACK, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE FSE FOLLOWED UP WITH THE CUSTOMER WHO STATED THAT THE ROBOT HAD BEEN USED FOR SEVERAL CASES AND NO ERROR... |
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 BILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE SYSTEM DISPLAYED A PROMPT INDICATING ¿OUT OF RANGE OF MOTION¿ AND THE SURGEON¿S ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A SYSTEM PROMPT AND AN INABILITY TO CONTROL A UNIVERSAL SURGICAL MANIPULATOR (USM) ARM, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL, INC. (ISI) FIELD SERVICE ENGINEER (FSE) FOLLOWED THROUGH AND CONTACTE... |
Brand Name:DAVINCI XDevice Problem: Entrapment of DevicePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CYSTECTOMY SURGICAL PROCEDURE, THE INSTRUMENT DID NOT RELEASE TISSUE WHEN THE CANNULA WAS DISLODGED. THE UNIVERSAL SURGICAL MANIPULATOR USM... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER, 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 ISI FSE REPLACED THE UNIVERSAL SURGICAL ... |
Brand Name:DAVINCI XIDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: Myocardial InfarctionEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA PROCEDURE, WHILE BRINGING THE PATIENT INTO THE ROOM, THE PATIENT CODED (EXPERIENCE... | BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF A DA VINCI SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. THEREFORE, NO PRODUCT IS EXPECTED TO BE RETURNED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. A ... |
Brand Name:DAVINCI XIDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE SITE DISCOVERED THAT THE ERBE GENERATOR FOOT PEDAL WAS NOT WORKING. THE SITE CHECKE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INTEGRATED ELECTROSURGICAL UNIT EXTERNAL FOOT PEDALS WERE 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... |
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 HYSTERECTOMY - MALIGNMENT SURGICAL PROCEDURE, A CUSTOMER CALLED INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SERVICE ENGINEER (TSE) ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING ERROR 252, 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 THE MTM A... |
Brand Name:ENDOWRISTDevice Problem: Material Integrity ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MARYLAND BIPOLAR FORCEPS INSTRUMENT HAD AN INDENTATION ON THE PULLEY OF THE CABLE WHEN THE JAWS WERE OPEN. THE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN INDENTATION ON THE PULLEY OF THE 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 INSTRUMENT WAS AN... |
Brand Name:ENDOWRISTDevice Problem: Insufficient InformationPatient Problem: Burn(s)Event Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE PATIENT EXPERIENCED ¿A LITTLE SCORCHED TISSUE¿ AT ONE OF THE INCISION PORTS WHERE THE PATIENT¿S ABDOMEN MET AN 8... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE OPERATIVE COMPLICATION CANNOT BE DETERMINED. THE DEVICE INVOLVED WITH THIS EVENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. REVIEW OF THE SYSTEM LOGS WAS COMPLETED, AND NO REL... |
Brand Name:DAVINCI XIDevice Problem: Battery ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE PATIENT SIDE CART (PSC) WAS RUNNING ON BATTERY. THE SURGEON OPTED TO NOT PERFORM THE HARD POWER CYCLE AND ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE PSC WAS RUNNING ON BATTERY, 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. BASED ... |
Brand Name:SUREFORMDevice Problem: Failure to Form Staple; Firing ProblemPatient Problem: Foreign Body In Patient; Unspecified Tissue InjuryEvent Description: ON 10-MAR-2023, INTUITIVE SURGICAL, INC. (ISI) RECEIVED FDA MDR REPORT #MW5115270 STATING: "DURING CASE OF ROBOTIC LAPAROSCOPIC SLEEVE GASTRECTOMY, ROBOTIC STAPL... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE AND INCOMPLETE STAPLE LINE CANNOT BE DETERMINED. THE CUSTOMER CONFIRMED THE PRODUCT IS NOT AVAILABLE FOR RETURN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED. THERE WERE TWO STAPLERS USED DURING THIS EV... |
Brand Name:ENDOWRISTDevice Problem: Failure to Cut; Difficult to Open or ClosePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) DIDN'T CUT. THE PR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE MCS INSTRUMENT DIDN'T CUT AND GOT STUCK ON TO THE TISSUE, 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 ... |
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 FENESTRATED BIPOLAR FORCEPS INSTRUMENT INSULATION HAD A TEAR. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY. INT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSULATION DAMAGE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED ISSUE. FAILURE ANA... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RADICAL EXTRAPERITONEAL PROSTATECTOMY WITH LYMPHADENECTOMY SURGICAL PROCEDURE, THE 0 DEGREE ENDOSCOPE ROTATION DID NOT MATCH WITH THE HOR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING NON-INTUITIVE MOTION, AN INVESTIGATION IS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER SWITCHED TO SPARE ENDOSCOPE TO RESOLVE THE REPORTED ISSUE. NO SITE VISIT WAS CONDUCTED. THE S... |
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 RECTOPEXY SURGICAL PROCEDURE, A PIECE OF THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT BROKE OFF. THE FRAGMENT WAS RETRIEVED DURING THE SAME S... | INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE MEDIUM-LARGE CLIP APPLIER INSTRUMENT TO PERFORM FAILURE ANALYSIS (FA). FA INVESTIGATIONS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT. UPON VISUAL AND MICROSCOPIC INSPECTION, NO DAMAGE WAS FOUND TO THE WRIST ASSEMBLY. NO CABLE DAMAGE OR MISALIGNMENT OF GRI... |
Brand Name:DAVINCI XIDevice Problem: Output ProblemPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED OOPHORECTOMY SURGICAL PROCEDURE, THE SYSTEM WAS EXPERIENCING ERBE GENERATOR ERRORS. AT TIME OF THE CALL, THE MONOPOLAR SELECTION OPTIONS WERE GR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SYSTEM WAS EXPERIENCING ERBE 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 EVEN... |
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 MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, THERE WERE ISSUES WITH VESSEL SEALER EXTEND (VSE) INSTRUMENT. CUSTOMER STATED THAT THEY WERE G... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE E-100 GENERATOR FAILED TO FIRE, 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 E-100 GENERATOR WAS ANALYZED AND FOUND TO REPLICA... |
Brand Name:DAVINCI XIDevice Problem: No Display/ImagePatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE VISION IN THE RIGHT EYE OF THE SURGEON SIDE CONSOLE (SSC) WAS MISSING. THE INTUITIVE SURGICAL, INC... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE VISION IN THE RIGHT EYE OF THE SURGEON SIDE CONSOLE (SSC) WAS MISSING, 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 FUR... |
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 PROSTATECTOMY SURGICAL PROCEDURE, THE SYSTEM WAS RECEIVING A MESSAGE STATING INSERTION AXIS WAS NOT FREE TO MOVE ON ARM 3. THE CUS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE SYSTEM WAS RECEIVING A MESSAGE STATING INSERTION AXIS WAS NOT FREE TO MOVE ON ARM 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 CUSTOM... |
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 INCISIONAL HERNIA SURGICAL PROCEDURE, THE SCREW HOLDING THE CALIPERS IN PLACE OF THE PROGRASP FORCEPS INSTRUMENT FELL OFF AND INTO THE PA... | INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PROGRASP FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION FOUND THE PRIMARY FAILURE OF MISSING GRIP PIN TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND... |
Brand Name:ENDOWRISTDevice Problem: Unintended MovementPatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT-HEMICOLECTOMY SURGICAL PROCEDURE, THE STAPLER 45 INSTRUMENT ARM "FREE SPINS AND NO TENSION." THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING TENSION ON THE STAPLER 45 INSTRUMENT AND ARM FREE SPIN, 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 STAPLER 45 INSTRUMENT WAS AN... |
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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SYSTEM HAD REPEATED RECOVERABLE FAULT 31243. INTUITIVE SURGICAL, INC. (ISI) TECHNI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING REPEATED RECOVERABLE FAULT 31243, 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... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE. THE PROCEDURE WAS COMPLETED. THE LESION WAS A 2.0 CM CAVI... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE SUBMITTED. AS OF 16-MAR-2023, A SYSTEM LOG REVIEW CA... |
Brand Name:SINGLE-SITEDevice Problem: Detachment of Device or Device ComponentPatient Problem: Foreign Body In PatientEvent Description: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, A SINGLE-SITE CADIERE FORCEPS INSTRUMENT BROKE INSIDE A PATIENT. AN INTUITIVE SURGICAL, INC. (IS... | INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. ALTHOUGH THE COMPLAINT REGARDING INSTRUMENT BREAKAGE WAS NOT CONFIRMED BY FAILURE ANALYSIS SINCE THE INSTRUMENT WAS NOT RETURNED, THE INFORMATION GATHERED INDICATES THAT THE DEVICE DID CONTRIBUTE TO TH... |
Brand Name:IONDevice Problem: Appropriate Term/Code Not AvailablePatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE AND DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. THE LESION BIOPSIED WAS 1.5CM AND IN THE RIGHT UPP... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THE PHYSICIAN REPORTED THE LESION LOCATION WAS HIGH RISK FOR POTENTIAL PNEUMOTHORAX. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. A REVIEW OF THE SITE'S SYSTEM ... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of Device; Material FragmentationPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, A MARYLAND BIPOLAR FORCEPS INSTRUMENT'S COATING ON BLACK CABLE WAS NOTED TO BE PEELING AWAY PER CENTRAL ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT A BLACK CABLE COATING WAS PEELING ON THE MARYLAND BIPOLAR FORCEPS (MBF) INSTRUMENT, 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... |
Brand Name:NONEDevice Problem: Image Orientation Incorrect; Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE 30-DEGREE ENDOSCOPE EXHIBITED INVERTED MOVEMENT AFTER THE POSITI... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE ENDOSCOPE EXHIBITED INVERTED MOVEMENT AFTER THE POSITION WAS FLIPPED FROM UP TO DOWN, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN INTUITIVE SURGICAL (IS) TECHNICAL SUPPORT ENGINEER (TSE) WAS CHECKED THE LOGS AND ... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PARAESOPHAGEAL HIATAL HERNIA SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND INSTRUMENT HAD A SLIGHT MOVEMENT/JUMP DURING THE CUT. THE INT... | INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON 13-APR-2023 AND OBTAINED THE FOLLOWING ADDITIONAL EVENT INFORMATION: THE SURGEONS HEAD WAS INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER. THE ¿JUMP¿ ONLY OCCURRED WHILE DELIVERING ENERGY WITH THE VESSEL SEALER EXTEND. THE INSTRUMENT MO... |
Brand Name:IONDevice Problem: Adverse Event Without Identified Device or Use ProblemPatient Problem: PneumothoraxEvent Description: IT WAS REPORTED THAT DURING AN ION ENDOLUMINAL LUNG BIOPSY PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX REQUIRING A CHEST TUBE AND HOSPITALIZATION. THE PROCEDURE WAS ABORTED. THERE IS N... | BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE CUSTOMER REPORTED COMPLICATION CANNOT BE DETERMINED. THERE IS NO ALLEGATION THAT A MALFUNCTION OF AN ION SYSTEM, INSTRUMENT, OR ACCESSORY OCCURRED. AS OF 21-MAR-2023, A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED BY AN INTUITIVE... |
Brand Name:SINGLE-SITEDevice 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 WRISTED NEEDLE DRIVER INSTRUMENT MOVED IN THE OPPOSITE DIRECTION. A BACKUP INSTRUMENT ... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE INSTRUMENT MOVED WITH UNINTUITIVE MOTION, 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 ... |
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 INSTRUMENT WOULD NOT OPEN. THE PROCEDURE WAS COMPLETED AS PLANNED WITH NO REPORTED ... | 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 (FA). THE MEDIUM-LARGE CLIP APPLIER INSTRUME... |
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 OVARIAN CYSTECTOMY SURGICAL PROCEDURE, THE SURGEON NOTICED THERE WAS SEVERE DAMAGE TO THE TIP/JAWS OF THE FORCE BIPOLAR INSTRUMENT AF... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING SEVERE DAMAGE TO THE TIP/JAWS, AN INVESTIGATION IS PENDING TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE FORCE BIPOLAR INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE ... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of DevicePatient Problem: Insufficient InformationEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, A PLASTIC PIECE FROM THE DISTAL END OF A FENESTRATED BIPOLAR FORCEPS INSTRUMENT CHIPPED OFF. AT THIS TIME, IT IS UNKNOWN IF THE FRAGMENT FELL INS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A PLASTIC PIECE FROM THE DISTAL END CHIPPED OFF, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE D... |
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 SYSTEM INDICATED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS OUT OF LIVES, BUT THE LIFE INDICATOR STILL R... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A LIFE INDICATOR 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... |
Brand Name:ENDOWRISTDevice Problem: Failure to CutPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT DID NOT CUT ENOUGH ANYMORE AND GOT STUCK INTO TISSUE. THE PROCEDURE WAS REPORT... | BASED ON THE CLAIM THAT THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT DID NOT CUT ENOUGH ANYMORE AND GOT STUCK INTO TISSUE, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. AN RMA HAS BEEN ISSUED REQUESTING TO HAVE THE INTUITIVE SURGICAL, INC. (ISI) DEVICE RETURNED. ADDITIONAL INFORMATION... |
Brand Name:ENDOWRISTDevice Problem: Unintended System MotionPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT ROTATED THE WRONG WAY. THE PROCEDURE WAS COMPLETE... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE MBF INSTRUMENT TIP ROTATED THE WRONG WAY, 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 MBF INSTRUMENT WAS ANALYZED AND FO... |
Brand Name:ENDOWRISTDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING CENTRAL PROCESSING, THE 8MM TIP-UP FENESTRATED GRASPER INSTRUMENT HAD PHYSICAL DAMAGE. THERE WAS NO PATIENT INVOLVEMENT. | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING PHYSICAL DAMAGE, 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 FORCE BIPOLAR INSTRUMENT WAS ANALYZED, AND A BROKEN GRIP AT THE BASE ... |
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 LOW ANTERIOR RESECTION SURGICAL PROCEDURE, THE SMALL GRASPING RETRACTOR INSTRUMENT WAS NOT GRASPING. THE PROCEDURE WAS COMPLETED WIT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING GRIP FAILURE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A SMALL GRASPING RETRACTOR INSTRUMENT AND PERFORMED THE FAILURE ANALYSIS (FA). THE FA FOUND TO HAVE A BROKEN PITCH CABLE AT... |
Brand Name:FLEXISIONDevice Problem: Detachment of Device or Device ComponentPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED, THAT DURING AN ION ENDOBRONCHIAL LUNG BIOPSY PROCEDURE, THE BIOPSY NEEDLE WAS EXTENDED AND BROKE INSIDE THE SHEATH. THE DIAGNOSTIC PROCEDURE WAS COMPL... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKE. 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. ISI HAS NOT RECEIVED THE BIOPSY NEEDLE INVOLVED WITH TH... |
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 ESOPHAGECTOMY TRANSTHORACIC-CHEST ANASTOMOSIS SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE SURGEON WAS CAUTERIZING USING A HARMONIC ACE INSTR... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING BROKEN TIP IN 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 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 PULMONARY WEDGE RESECTION SURGICAL PROCEDURE, WHILE INTRODUCING THE TIP-UP FENESTRATED GRASPER INSTRUMENT INSIDE THE TROCAR, THE FIRST AS... | BASED ON THE CURRENT INFORMATION PROVIDED, THE CAUSE OF THE CUSTOMER REPORTED FAILURE MODE CANNOT BE DETERMINED. INTUITIVE SURGICAL, INC (ISI) HAS NOT RECEIVED THE TIP UP FENESTRATED GRASPER INSTRUMENT INVOLVED WITH THIS COMPLAINT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS E... |
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, A PIECE OF THE TIP OF THE TIP-UP FENESTRATED GRASPER INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT A PIECE OF THE TIP OF THE INSTRUMENT BROKE OFF AND FELL INTO THE PATIENT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE TIP-UP FENESTRATED GRASPER INSTRUMENT WAS ANALYZED, AND FAILURE ANALYSIS INVESTIGATIONS WERE ABLE... |
Brand Name:ENDOWRISTDevice Problem: Thermal Decomposition of Device; Material Split, Cut or TornPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE INSTRUMENTS INSULATION WAS DAMAGED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJU... | BASED ON THE CLAIM AGAINST THE PRODUCT NOTING THE INSTRUMENTS INSULATION WAS DAMAGED, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND FAILURE ANALYSIS INVESTIGATIONS THEY WERE ABLE TO REPLICATE AND CONFIRM THE REPORTED ISSUE... |
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 SALPINGECTOMY SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT RUBBER AROUND THE CABLE IS BURNT. THE PROCEDURE WAS... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THE RUBBER AROUND THE CABLE IS BURNT, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS REPLICATED AND CONFIRMED THE CUSTOMER REPORTED COM... |
Brand Name:NONEDevice Problem: Image Orientation IncorrectPatient Problem: No Clinical Signs, Symptoms or ConditionsEvent Description: IT WAS REPORTED THAT DURING A DA VINCI ASSISTED SACROCOLPOPEXY SURGICAL PROCEDURE, THE CUSTOMER ENCOUNTERED AN IMAGE ORIENTATION ISSUE WITH THE ENDOSCOPE. THE CUSTOMER CHANGED OUT THE 3... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING AN IMAGE ORIENTATION ISSUE, AN INVESTIGATION IS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. THE REPORTED EVENT WAS ADDRESSED WITH PHONE SUPPORT. THE CUSTOMER REPLACED THE ENDOSCOPE TO RESOLVE THE REPORTED ISSUE. NO SITE VISIT WAS CONDUCTED. THE ... |
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 8 MM LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT WAS UNABLE TO BE USED FOR CLIP APPLICATION. USE OF THE INSTRUMEN... | BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING THAT THE INSTRUMENT WAS UNABLE TO BE USED FOR CLIP APPLICATION, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT FOR FAILURE ANALYSIS. THE 8 MM LARGE HEM-O-LOK CLIP APP... |
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