BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 23009084 · Received September 9, 2025

    Report

    Report Number
    2955842-2025-36520
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 16, 2025
    Report Date
    August 16, 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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR CURVED SCISSORS INSTRUMENT WAS FOUND TO HAVE BLADE DAMAGE. BOTH OF THE BLADE EDGES WERE INDENTED. THE BLADE INDENTATION DID CAUSE THE CUT TEST FAILURE AND CAUSED THE BLADES NOT TO OPEN OR CLOSE PROPERLY. THE CUTTING EDGE HAD CORROSION THAT WOULD HAVE CONTRIBUTED TO THE BLADE DAMAGE OR CUTTING FAILURE. THE PROBABLE ROOT CAUSE OF NICKS AND GOUGES ON THE INSTRUMENT BLADES IS ATTRIBUTED TO USE-RELATED DAMAGE WHEN ATTEMPTING TO CUT INCOMPATIBLE MATERIAL OR MISHANDLING THE INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS INSTRUMENT WOULD NOT ARTICULATE CORRECTLY. 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
    2826701 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-21 K10241101 0401 00886874112298

    Patients

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