BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22206965 · Received June 13, 2025

    Report

    Report Number
    2955842-2025-25355
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 22, 2025
    Report Date
    May 22, 2025
    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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT FOR EVALUATION. HOWEVER, THE FAILURE ANALYSIS HAS NOT BEEN COMPLETED YET. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE MONOPOLAR CURVED SCISSORS INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. THE INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE TO THE TIP. ONE OF THE BLADE EDGES WAS INDENTED, WHICH PREVENTS THE BLADES FROM OPENING AND CLOSING PROPERLY AS REPORTED BY THE CUSTOMER. THE BLADE INDENTATION DID NOT RESULT IN THE CUT TEST FAILURE. THE CUTTING EDGE DID NOT EXHIBIT ANY SIGNS OF CORROSION THAT WOULD HAVE CONTRIBUTED TO THE BLADE DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED UNILATERAL INGUINAL HERNIA SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT DID NOT FULLY CLOSE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344282 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K13250227 0076 00886874112298

    Patients

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