BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18097727 · Received November 8, 2023

    Report

    Report Number
    2955842-2023-20062
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    July 20, 2023
    Report Date
    October 13, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT FOR FAILURE ANALYSIS. INITIAL INSPECTION IDENTIFIED THERMAL DAMAGE TO THE PROXIMAL CLEVIS. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT WAS ABLE TO RELEASE ENERGY AND NO ARCING WAS OBSERVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER SUCCESSFULLY COMPLETING A DA VINCI-ASSISTED LIVER RESECTION SURGICAL PROCEDURE, INSPECTION IDENTIFIED THE SURFACE OF THE SHAFT OF THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT WAS BROKEN. NO FRAGMENT FELL INSIDE THE PATIENT. NO KNOWN IMPACT OR PATIENT CONSEQUENCE WAS REPORTED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE PCH INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO DAMAGE OBSERVED. THE CUSTOMER INDICATED THAT THE INSTRUMENT CAME INTO CONTACT WITH ANOTHER ENERGY INSTRUMENT DURING THE PROCEDURE. THERE WAS NO OCCURRENCE OF INSTRUMENT ARCING OBSERVED DURING THE PROCEDURE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1833704 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-14 N12191209 0022 00886874112311

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES.