BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21588659 · Received March 12, 2025

    Report

    Report Number
    2955842-2025-07678
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    January 15, 2025
    Report Date
    November 5, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119754
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT INVOLVED IN THIS COMPLAINT HAS BEEN RECEIVED AND TESTED BY FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE A DAMAGED GRIP CABLE.

    Additional Manufacturer Narrative · 0

    CORRECTION: H8. WAS UPDATED TO INITIAL USE OF DEVICE. CORRECTION TO ANNEX CODES: ANNEX CODE A WAS UPDATED TO A040605.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TRAINING/DEMO OF THE DA VINCI SYSTEM, THE 8MM LARGE NEEDLE DRIVER INSTRUMENT HAD AN ISSUE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS FRYING NOTED ON CABLE, NOT NOTED ON BLACK CABLE. NO PHYSICAL DAMAGE LOCATED AT THE DISTAL END (TIPS) OR THE PROXIMAL END (HOUSING). NO MATERIAL MISSING OR DETACHED FROM THE INSTRUMENT AT THE DISTAL END. NO ALLEGATION OF ARCING DURING THE PROCEDURE. NO LOSS OF CAUTERY DURING THE PROCEDURE. THERE WAS NO ISSUE WITH THE JAWS OF THE INSTRUMENT MOVING IN THE WRONG DIRECTION/OPPOSITE THE SURGEON CONTROLS. NO INJURIES TO THE PATIENT AS A RESULT OF THE REPORTED FAILURE.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175195 ENDOWRIST LARGE NEEDLE DRIVER NAY INTUITIVE SURGICAL, INC 471006-12 K10211122 0474 00886874119754

    Patients

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