BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21308936 · Received February 4, 2025

    Report

    Report Number
    2955842-2025-01131
    Event Type
    Malfunction
    Date Received
    February 4, 2025
    Date of Event
    January 30, 2025
    Report Date
    January 9, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID NOT RECEIVE THE VESSEL SEALER EXTEND INSTRUMENT(S) INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER EXPLAINED THAT THE VESSEL SEALER (VS) INSTRUMENT THEY INSTALLED ON UNIVERSAL SURGICAL MANIPULATOR (USM) 1 WAS WORKING BACKWARDS. THE REPORTER EXPLAINED IF THEY MOVED THE INSTRUMENT UP THE INSTRUMENT MOVED DOWN AND IF THEY MOVED THE INSTRUMENT LEFT THE INSTRUMENT MOVED RIGHT. CUSTOMER REPORTED THE INSTRUMENTS IN THE OTHER USM WERE WORKING NORMALLY. THE CUSTOMER TRIED TO RE-DRAPE THE USM, REPLACED THREE INSTRUMENTS, AND POWER CYCLED THE SYSTEM WITH NO CHANGE. THE CUSTOMER WAS ABLE TO INSTALL A DIFFERENT INSTRUMENT INTO THE USM AND THE NEW INSTRUMENT WORKED WITH NO ISSUES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47438 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422 K11241024 0512

    Patients

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