BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19936034 · Received August 8, 2024

    Report

    Report Number
    2955842-2024-17951
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    September 20, 2023
    Report Date
    July 17, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) HAS RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT TO PERFORM FAILURE ANALYSIS; HOWEVER, THE EVALUATION IS NOT YET COMPLETE. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE THE PRODUCT IS EVALUATED AND/ OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VESSEL SEALER EXTEND INSTRUMENT AND COMPLETED THE DEVICE EVALUATION. THE VESSEL SEALER EXTEND INSTRUMENT WAS ANALYZED AND THE COMPLAINT WAS NOT CONFIRMED OR REPLICATED BY FAILURE ANALYSIS. A VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE. THE BLADE WAS FOUND INTACT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE GRIPS OPENED AND CLOSED PROPERLY. THE INSTRUMENT CORD WAS CUT SO A CUTTING TEST COULD NOT BE PERFORMED. NO PRODUCT ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SLEEVE GASTRECTOMY SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT HAD CUTTING ISSUE AND WAS FOUND TO HAVE NO BLADE. THERE WAS NO REPORT OF FRAGMENT(S) FALLING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2397668 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L83230706 0185 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES