BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST SP

    MDR report key: 21999374 · Received May 10, 2025

    Report

    Report Number
    2955842-2025-19917
    Event Type
    Malfunction
    Date Received
    May 10, 2025
    Date of Event
    April 15, 2025
    Report Date
    April 15, 2025
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874114339
    PMA / PMN Number
    K182371
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS FOUND TO HAVE A BROKEN MOLDED INSULATOR ON THE UPPER JAW. THE BROKEN PIECE MEASURES APPROXIMATELY 2.90MM X 7.85MM AND WAS NOT RETURNED WITH THE INSTRUMENT. THE GRIP BASE FOR THE GRIP WITH THE CRACKED MOLDED INSULATOR DOES NOT APPEAR TO BE BENT. THE INSTRUMENT WAS FOUND TO HAVE A DETACHED FRAGMENT. THE FRAGMENT BROKEN OFF FROM THE INSTRUMENTS MOLDED INSULATOR. THE BROKEN PIECE WAS NOT RETURNED WITH THE INSTRUMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED URETHROPLASTY SURGICAL PROCEDURE THAT THE TIP OF THE FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT BROKE. THE PROCEDURE WAS COMPLETED WITH NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED ADDITIONAL INFORMATION: THE SURGEON WAS REPORTEDLY USING THE INSTRUMENT INCORRECTLY, WHICH CAUSED THE TIP TO BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789743 ENDOWRIST SP FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 430011-57 U10240229 0024 00886874114339

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female DA VINCI INSTRUMENTS AND ACCESSORIES