BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15514822 · Received September 30, 2022

    Report

    Report Number
    2955842-2022-14277
    Event Type
    Malfunction
    Date Received
    September 30, 2022
    Date of Event
    August 23, 2022
    Report Date
    August 30, 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 INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, THE INSTRUMENT WAS FOUND WITH DAMAGED INSULATION TO THE CONDUCTOR WIRE NEAR THE DISTAL IDLER PULLEY. MATERIAL APPEARED TO BE LIFTED OFF, EXPOSING THE BARE WIRE. NO MATERIAL APPEARED TO BE MISSING. THE ELECTRICAL CONTINUITY TEST STILL PASSED. NO THERMAL DAMAGE WAS OBSERVED. THE ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE. A REVIEW OF THE DEVICE LOGS FOR THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT (PART# 471205-17 / LOT/SERIAL# K12220314-0109) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER THIS REVIEW OF THE LOGS, THE INSTRUMENT WAS LAST USED ON (B)(6) 2022 VIA SYSTEM SERIAL# (B)(4). NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD CONDUCTOR WIRE DAMAGE DURING A PROCEDURE. THE DAMAGED/BROKEN CONDUCTOR WIRE HAS POTENTIAL FOR 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD CONDUCTOR WIRE INSULATION DAMAGE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE MEDICAL ENGINEER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO ABNORMALITY WAS FOUND. IT WAS UNKNOWN IF THE INSTRUMENT HAD COLLIDED WITH ANY OTHER INSTRUMENTS OR TOOL DURING THE PROCEDURE. THE INSTRUMENT WAS FOUND TO HAVE DAMAGE PRIOR TO CENTRAL PROCESSING. IT WAS UNKNOWN IF THE INSTRUMENT WAS INSPECTED FOR DAMAGE AFTER THE COMPLETION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886451 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K12220314 0109 00886874119808

    Patients

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