BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20869812 · Received December 6, 2024

    Report

    Report Number
    2955842-2024-22906
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 12, 2024
    Report Date
    November 12, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112298
    PMA / PMN Number
    K220023
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL INC. (ISI) RECEIVED THE 8MM MONOPOLAR CURVED SCISSORS INSTRUMENT FOR FAILURE ANALYSIS INVESTIGATION. THE INSTRUMENT WAS ANALYZED AND WAS FOUND TO HAVE BLADE DAMAGE AT THE MIDPOINT OF THE BLADE. BOTH OF THE BLADE EDGES WERE INDENTED. THE BLADE INDENTATION DID CAUSE THE CUT TEST FAILURE. THE CUTTING EDGE HAD CORROSION THAT WOULD HAVE CONTRIBUTED TO THE BLADE DAMAGE OR CUTTING FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM MONOPOLAR CURVED SCISSORS INSTRUMENT WAS NOT WORKING. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT PRESENTED LOW/INTERMITTENT ENERGY DELIVERY AND REVERSED/UNCONTROLLED MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2516157 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-19 K13240627 0523 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES.