BEUDAMED
    FDA Adverse Event Other Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 1022533 · Received March 25, 2008

    Report

    Report Number
    2955842-2008-00158
    Event Type
    Other
    Date Received
    March 25, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 21, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MSC TIP COVER ACCESSORY WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THE TIP COVER HAS THREE HOLES BURNED THROUGH THE SILICONE. THE HOLES RANGE IN SIZE FROM .008 INCH IN DIAMETER TO .070 INCH WIDE AND WAS OBLONG IN SHAPE. THE HOLES ARE POSITIONED AT .300 INCH, .540 INCH AND .565 INCH ABOVE THE SILICONE TO SLEEVE INTERFACE, WITH THE .008 INCH HOLE ADJACENT TO THE OBLONG HOLE. ALL HOLES EXHIBIT LOCALIZED MELTING OF THE SILICONE, INDICATING MULTIPLE ARCING EVENTS OCCURRED. ENGINEERING DETERMINED THE ARCING IS DUE TO INSUFFICIENT DIELECTRIC STRENGTH OF THE SILICONE, AND HIGH CAUTERY SETTINGS PER THE IFU, MAXIMUM MONOPOLAR SETTING FOR VALLEYLAB FORCE FX GENERATOR IN COAG FULGURATE MODE IS 38 WATTS, HOWEVER, SITE HAS BEEN KNOWN TO USE 20 TO 50 WATTS DURING THEIR SURGICAL PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE MIDDLE OF A DA VINCI PROCTECTOMY PROCEDURE, WHILE DISSECTING THE PROSTRATE, THE SURGEON NOTICED SPARKS AND A BURN MARK WAS OBSERVED ON THE PROSTATE IN A DIFFERENT LOCATION. THE SURGEON IMMEDIATELY STOPPED THE SURGICAL TASK BEING PERFORMED AND THE MONOPOLAR CURVED SCISSORS MCS TIP COVER ACCESSORY WAS INSPECTED, AT THAT TIME A HOLE IN THE MCS TIP COVER WAS NOTICED. THE MCS TIP COVER WAS REPLACED AND THE PLANNED PROCEDURE WAS COMPLETED WITH NO DELAY. NO ADDITIONAL PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8MM MCS TIP COVER ACCESSORY ELECTROSURGICAL INSTRUMENT ACCESSORY GEI INTUITIVE SURGICAL, INC. 400180-05 C8015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other A CANNULA ACCESSORY AND AN ELECTROSURGICAL UNIT| DA VINCI SURGICAL SYSTEM| MCS INSTRUMENT