BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22065911 · Received May 21, 2025

    Report

    Report Number
    2955842-2025-21523
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 30, 2025
    Report Date
    May 2, 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
    UT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE PRODUCT IS RETURNED AND EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    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 AT THE MIDPOINT OF THE BLADE. ONE OF THE BLADE EDGES WAS INDENTED. 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 BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE 8MM MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT WAS NOT OPENING OR CLOSING 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
    51337 ENDOWRIST MONOPOLAR CURVED SCISSORS NAY INTUITIVE SURGICAL, INC 470179-23 K12250227 0426 00886874112298

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.