BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22006483 · Received May 12, 2025

    Report

    Report Number
    2955842-2025-20186
    Event Type
    Malfunction
    Date Received
    May 12, 2025
    Date of Event
    April 16, 2025
    Report Date
    April 16, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE PERMANENT CAUTERY HOOK INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED INVESTIGATIONS. VISUAL INSPECTION DISPLAYED NO SIGNS OF PHYSICAL DAMAGE. NO MISSING COMPONENTS OBSERVED. THE INSTRUMENT WAS RETURNED WITH A REPORT COMPLAINT THAT DOES NOT AFFECT FUNCTIONALITY AND IS A PART OF THE INSTRUMENTS DESIGN.

    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) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE DISK CAME OFF WHILE WASHING IN THE CENTRAL STERILE DEPARTMENT. NO DISK FRAGMENTS WERE LEFT BEHIND AND THERE WERE NO POST OPERATIVE TESTS OR INJURY TO THE PATIENT.

    Description of Event or Problem · 0

    REFER TO H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE PERMANENT CAUTERY HOOK WAS FOUND WITH THE DIAL DETACHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1825163 ENDOWRIST PERMANENT CAUTERY HOOK NAY INTUITIVE SURGICAL, INC 470183-18 K15241115 0019 00886874112311

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES.