BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 24273757 · Received February 5, 2026

    Report

    Report Number
    2955842-2026-03373
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    July 31, 2025
    Report Date
    February 5, 2026
    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
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE FENESTRATE BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN CONDUCTOR WIRE AT THE PROXIMAL END NEAR THE MAIN TUBE AND ROLL GEAR JUNCTION. THE WIRE BREAK HAPPENED AROUND 3.605 IN FROM THE CONDUCTOR WIRE PROXIMAL PIN CONNECTION. THERE WERE NO SIGNS OF THERMAL DAMAGE OBSERVED ON ADJACENT COMPONENTS. THE COMPLAINT REGARDING A RECOGNITION ISSUE WAS NOT CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO THE START OF A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT RECOGNIZED. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO INDICATION OR OBSERVATION OF ARCING DURING THE PROCEDURE. THE ISSUE WITH THE INSTRUMENT WAS NOTICED BEFORE SURGERY AND ANESTHESIA, SO THE INSTRUMENT WAS NOT USED ON THE PATIENT. THEREFORE, THERE WERE NO SIGNS OF ARCING, SUCH AS SPARKING OR SMOKE, AND NO OTHER INSTRUMENTS WERE ASSOCIATED WITH THE COMPLAINT. ADDITIONALLY, NO PATIENT INJURY OR ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334871 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-19 K12240912 0225 00886874119808

    Patients

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