BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 20273463 · Received September 20, 2024

    Report

    Report Number
    2955842-2024-19512
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    May 10, 2024
    Report Date
    August 28, 2024
    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
    IN
    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 ANALYZED AND WAS NOT ABLE TO DELIVER BIPOLAR ENERGY DURING IN-HOUSE TESTING. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM. THE INSTRUMENT PASSED RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE INSTRUMENT FAILED CONTINUITY AND DID NOT RELEASE ENERGY ON SEVERAL ATTEMPTS. THE INSTRUMENT WAS NOT FULLY FUNCTIONAL. ADVANCED FAILURE ANALYSIS CONFIRMED INITIAL FINDINGS. THE INSTRUMENT PASSED ENERGY RECOGNITION, AS THE INTEGRATED ELECTROSURGICAL UNIT (IESU) OR ERBE GENERATOR RECOGNIZED THE INSTRUMENT WHEN PLUGGED IN. HOWEVER, THE INSTRUMENT DID FAIL CONTINUITY TEST FOR ONE OF THE GRIPS. NO OBVIOUS DAMAGE WAS SEEN ON THE CONDUCTOR WIRE AT THE DISTAL END THROUGH VISUAL AND MICROSCOPIC INSPECTION. THE HOUSING WAS REMOVED, AND NO RESIDUE OR CONTAMINATION WAS FOUND ON THE ENERGY INSTRUMENT IDENTIFICATION BIPOLAR (EIIB) BOARD PINS THAT COULD CAUSE A BREAK IN THE CIRCUIT FOR THE GRIP FAILING CONTINUITY. THE INSTRUMENT WAS THEN DISASSEMBLED, AND IT WAS NOTICED THAT THE CONDUCTOR WIRE HAD BROKEN AT THE PROXIMAL END, APPROXIMATELY 3.75 INCHES FROM THE CRIMP. RUBBING MARKS IN THE SAME DIRECTION AS THE LENGTH OF THE WIRE WERE NOTED, INDICATING POSSIBLE RUBBING AGAINST THE HYPO TUBES. THE COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS NOT ABLE TO DELIVER BIPOLAR ENERGY. THE BIPOLAR CABLES WERE CHANGED TO CHECK IF THERE WAS AN ISSUE WITH THE BIPOLAR CABLES. SAME ISSUE PERSISTED WITH ALTERNATE CABLES. AN ALTERNATIVE INSTRUMENT WAS CHECKED, AND IT WORKED FINE WITH ALL AVAILABLE BIPOLAR ENERGY CABLES. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495458 ENDOWRIST FENESTRATED BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471205-17 K10240216 0185 00886874119808

    Patients

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