BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 1232776 · Received November 14, 2008

    Report

    Report Number
    2955842-2008-01387
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Report Date
    November 14, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THE INSTRUMENT'S WRIST TO BE DETACHED BELOW THE PROXIMAL CLEVIS AND HALF OF THE MAIN TUBE INTERFACE WALL IS MISSING. ENGINEERING IS UNABLE TO CONFIRM SOME OF THE ITEMS MENTIONED IN THE COMPLAINT, AS ELECTRIC CONTINUITY IS GOOD FROM THE BANANA PLUG TO THE CUT END OF THE WIRE AND FROM THE CUT END OF THE WIRE TO THE HOOK. THERE IS NO EVIDENCE OF A BROKEN CABLE PRIOR TO THE WRIST BEING CUT OFF. THE INSTRUMENT MAY HAVE BECOME STUCK AND UNABLE TO BE REMOVED FROM CANNULA DUE TO A BREAK AT THE TUBE TO PROXIMAL CLEVIS INTERFACE. THE PROXIMAL CLEVIS IS INTACT, BUT A SECTION OF THE MAIN TUBE INTERFACE WALL MOST LIKELY COLLAPSED. THE WRIST WAS LIKELY CUT OFF TO ENABLE REMOVAL OF THE INSTRUMENT FROM CANNULA. NO OTHER DAMAGE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S NEPHRECTOMY SURGICAL PROCEDURE, THE ELECTRONIC POWER AT THE TIP OF THE PERMANENT CAUTERY HOOK INSTRUMENT DID NOT WORK. THE SURGICAL STAFF OBSERVED THE WRIST OF THE INSTRUMENT HAD BROKEN. THE SURGEON CUT THE TIP OF THE INSTRUMENT AND TOOK THE INSTRUMENT OUT OF THE INSTRUMENT ARM. THE SURGEON OBSERVED TWO SMALL BLACK PIECES IN THE PATIENT BODY. THE PIECES WERE RETRIEVED AND THE PLANNED SURGICAL PROCEDURE WAS COMPLETED WITH ANOTHER INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY HOOK INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420183-04 0609071 942

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ACCESSORIES| DA VINCI SURGICAL S SYSTEM| AN ELECTROSURGICAL UNIT