BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15595354 · Received October 13, 2022

    Report

    Report Number
    2955842-2022-14544
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    August 16, 2022
    Report Date
    September 13, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS REPLICATED THE REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF A BROKEN CONDUCTOR WIRE AT PROXIMAL END TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST BECAUSE OF A BROKEN CONDUCTOR WIRE AT THE MAIN TUBE/ROLL GEAR JUNCTION. AS A RESULT, ENERGY ACTIVATION WOULD NOT WORK WHEN ACTIVATED ON THE SYSTEM. THE ROOT CAUSE OF BROKEN CONDUCTOR WIRE WAS ATTRIBUTED TO A MANUFACTURING ISSUE. ADDITIONAL OBSERVATION, WHICH WAS NOT REPORTED BY SITE AND NOT RELATED THE REPORTED COMPLAINT, WAS THAT THE INSTRUMENT WAS FOUND WITH THERMAL DAMAGE AT THE BIPOLAR YAW PULLEY. BLACK CHAR MARKS WERE OBSERVED. ANY MATERIAL MISSING IS LIKELY TO BE THERMALLY INDUCED RATHER THAN MECHANICALLY INDUCED. NO INSULATION DAMAGE WAS OBSERVED ON THE CONDUCTOR WIRE AT THE WRIST ASSEMBLY. THE ROOT CAUSE OF THIS THERMAL DAMAGE WAS ATTRIBUTED TO MISHANDLING OR MISUSE. NO IMAGE/VIDEO INVESTIGATION REQUIRED AS NO IMAGE OR VIDEO CLIP FOR THE REPORTED EVENT WAS SUBMITTED FOR REVIEW. A REVIEW OF THE DEVICE LOGS FOR THE FENESTRATED BIPOLAR FORCEPS (PART# 471205-17/ LOT/SERIAL# (B)(4)) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE FENESTRATED BIPOLAR FORCEPS WAS LAST USED ON (B)(6) 2022 VIA SYSTEM SERIAL# (B)(4). THERE WERE 5 USES REMAINING AFTER THIS LAST USAGE. A REVIEW OF THE PROCEDURE LOG SHOWED THE SITE PERFORMED THIS RADICAL EXTRAPERITONEAL WITHOUT LYMPHADENECTOMY PROSTATECTOMY SURGICAL PROCEDURE ON (B)(6) 2022 VIA SYSTEM SERIAL# (B)(4). THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE FBF INSTRUMENT HAD CONDUCTOR WIRE DAMAGE AT THE PROXIMAL END AT THE MAIN TUBE/ROLL GEAR JUNCTION. THE DAMAGED/BROKEN CONDUCTOR WIRE HAS POTENTIAL FOR ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. IN ADDITION, THERMAL DAMAGE AT THE BIPOLAR YAW PULLEY IS EVIDENCE OF ELECTRICAL DISCHARGE AT A LOCATION OTHER THAN INTENDED. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN THE FOLLOWING FIELDS: G3, G6, H2, AND H4. ANALYSIS INFORMATION CAN BE FOUND IN THE FOLLOWING FIELD: H10. ADDITIONAL ANALYSIS WAS PERFORMED ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT BY AN ADVANCED FAILURE ANALYSIS ENGINEER. INITIAL FINDINGS WERE BOTH CONFIRMED. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FURTHER INSPECTED BUT NO OTHER DAMAGE WAS OBSERVED. THE ROOT CAUSE OF THE BROKEN CONDUCTOR WIRE IN THE PROXIMAL END WAS ATTRIBUTED TO MANUFACTURING, AND THE ROOT CAUSE OF THE THERMAL DAMAGE TO THE YAW PULLEY WAS ATTRIBUTED TO THE USER MISHANDLING OR MISUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED PROSTATECTOMY SURGICAL PROCEDURE, THE CUSTOMER REPORTED A PHYSICAL DAMAGE ON THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT. THE FBF INSTRUMENT WAS REPLACED. THE PROCEDURE WAS COMPLETING AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL. THERE WAS NO ARCING. THE CUSTOMER CONFIRMED THAT NO FRAGMENT FELL INSIDE OF THE PATIENT. THERE WAS NO PATIENT INJURY. PHOTOGRAPHIC IMAGES OF THE DEVICE(S) OR A VIDEO RECORDING OF THE PROCEDURE WERE NOT AVAILABLE FOR ISI REVIEW. INFORMATION REGARDING PATIENT DEMOGRAPHICS, RELEVANT TESTING, AND MEDICAL HISTORY WERE REQUESTED HOWEVER, THE REPORTER WAS NOT ABLE TO PROVIDE THAT INFORMATION.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1842860 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K10220404 0153 00886874119808

    Patients

    Seq Age Sex Outcome Treatment
    1 Male DA VINCI INSTRUMENTS AND ACCESSORIES