BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 21270993 · Received January 30, 2025

    Report

    Report Number
    2955842-2025-00990
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    August 30, 2024
    Report Date
    January 22, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) REQUESTED THAT THE FENESTRATED BIPOLAR FORCEPS BE RETURNED FOR FAILURE ANALYSIS INVESTIGATION. ISI HAS NOT RECEIVED THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND VISUAL INSPECTION DID NOT REVEAL ANY DAMAGE OR MISSING PARTS. THE INSTRUMENT WAS TESTED 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 INSTRUMENT PASSED ENERGY DELIVERY TESTING IN VARIOUS ORIENTATIONS. THE INSTRUMENT ALSO PASSED THE ELECTRICAL CONTINUITY TEST. THE INSTRUMENT WAS FULLY FUNCTIONAL. NO PRODUCT ISSUE WAS FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE INSTRUMENT DOES NOT CAUTERIZE / NO ENERGY - INSTRUMENT DOES NOT APPLY BIPOLAR ENERGY AS IT SHOULD. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621309 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K14240327 0153 00886874119808

    Patients

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