BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 22303567 · Received June 21, 2025

    Report

    Report Number
    2955842-2025-26468
    Event Type
    Malfunction
    Date Received
    June 21, 2025
    Date of Event
    April 8, 2025
    Report Date
    May 29, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119808
    PMA / PMN Number
    K214095
    Removal / Correction Number
    ISIFA2024-09-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A DAMAGED GRIP CABLE AT DISTAL END. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE 8MM FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT WORKING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL INC., (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WERE NO REPORTS OF ARCING FROM REPORTED INSTRUMENT. CUSTOMER DID NOT EXPERIENCE LOSS OF CAUTERIZATION FROM REPORTED INSTRUMENT. THERE WERE NO REPORTS OF INSTRUMENT JAWS MOVING IN OPPOSITE/WRONG DIRECTION. THE MOVEMENT OF INSTRUMENT WAS OBSERVED TO BE IN CORRECT DIRECTION. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1358004 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K10241009 0349 00886874119808

    Patients

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