BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOWRIST

    MDR report key: 20972787 · Received December 18, 2024

    Report

    Report Number
    2955842-2024-23450
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    November 8, 2024
    Report Date
    November 19, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE. THERE WAS NO DISCOLORATION, CORROSION, OR CONTAMINATION ON THE CABLE. FURTHER INSPECTION FOUND NO ABNORMALLY SHARP OR DAMAGED COMPONENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, A WIRE WENT OUT ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT INTRAOPERATIVELY. THE PROCEDURE WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE CUSTOMER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: A GENERAL REPORT WAS RECEIVED THAT DURING DA VINCI-ASSISTED SURGICAL PROCEDURES, THEY HAVE EXPERIENCED BROKEN FENESTRATED BIPOLAR FORCEPS INSTRUMENTS AT SEVERAL ASSOCIATED HOSPITALS. SPECIFIC EVENT AND DEVICE INFORMATION WAS NOT PROVIDED. IT WAS STATED THAT EACH PATIENT HAD INTRAOPERATIVE X-RAY IMAGING PERFORMED IN CASE A RETAINED PART OF THE WIRE DROPPED OFF IN THE PATIENT¿S CAVITY, WHICH THE CUSTOMER FELT WAS BECOMING A PATIENT SAFETY CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989359 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K15240530 0211

    Patients

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