BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22022978 · Received May 14, 2025

    Report

    Report Number
    2955842-2025-20488
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 21, 2025
    Report Date
    April 22, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112311
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MONOPOLAR INSTRUMENT WAS ANALYZED AND FOUND TO HAVE THE CERAMIC SLEEVE DISLODGED FROM ITS NORMAL POSITION ON THE YAW PULLEY. CERAMIC SLEEVE DOES NOT HAVE MISSING MATERIAL. THERE WAS MINIMAL SILICONE ADHESIVE ON THE YAW PULLEY AND INSIDE THE CERAMIC SLEEVE. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE PROBABLE ROOT CAUSE OF A DISLODGED CERAMIC SLEEVE IS ATTRIBUTED TO THE MANUFACTURING PROCESS. INSUFFICIENT SILICONE POTTING ON THE CERAMIC SLEEVE CAN RESULT IN ITS DISLODGEMENT.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PERMANENT CAUTERY HOOK (PCH) INSTRUMENT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS (FA) TESTING AND THE FA IS STILL IN PROGRESS. .

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE 8MM PERMANENT CAUTERY HOOK (PCH) INSTRUMENT'S TIP CAP PROTECTOR BROKE. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED BUT THE PATIENT OUTCOME WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089690 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-14 K12220228 0202 00886874112311

    Patients

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