BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21176101 · Received January 17, 2025

    Report

    Report Number
    2955842-2025-00596
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 26, 2024
    Report Date
    December 26, 2024
    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
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM PERMANENT CAUTERY HOOK INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND WAS PLACED ON THE IN-HOUSE SYSTEM IN ORDER TO REPLICATE CUSTOMER RELATED COMPLAINT. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT WAS CONNECTED TO AN IN-HOUSE ENERGY GENERATOR. THE INSTRUMENT FAILED THE ENERGY DELIVERY TEST. ELECTRICAL CONTINUITY TEST FAILED IN HOOK. NO DAMAGE FOUND ON CONDUCTOR WIRES.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (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.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM PERMANENT CAUTERY HOOK (PCH) INSTRUMENT WAS SMOKING OUT OF THE JOINTS. THE SMOKE SEEMED A LOT MORE THAN WHAT WAS SUPPOSED TO BE. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1006395 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-16 K13240606 0045 00886874112311

    Patients

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