BEUDAMED
    FDA Adverse Event Other Summary report: N

    8MM MCS TIP COVER ACCESSORY

    MDR report key: 1022532 · Received March 25, 2008

    Report

    Report Number
    2955842-2008-00149
    Event Type
    Other
    Date Received
    March 25, 2008
    Date of Event
    February 27, 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
    OTHER

    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 A 0.25" DIAMETER HOLE BURNED THROUGH THE SILICONE. THE HOLE IS LOCATED ALONG ONE OF THE PARTING LINES, ROUGHLY .215 INCHES ABOVE THE SILICONE TO ULTEM SLEEVE INTERFACE. THE SILICONE EXHIBITS LOCALIZED MELTING AROUND THE HOLE, INDICATING AN ARCING EVENT OCCURRED. ENGINEERING DETERMINED THE ARCING IS LIKELY DUE TO INSUFFICIENT DIELECTRIC STRENGTH OF THE SILICONE CAUSED BY A SMALL CRACK OR VOID. THE MCS INSTRUMENT WAS ALSO RETURNED FOR EVALUATION. ENGINEERING FOUND CHARRED MATERIAL ON ONE EAR OF THE PROXIMAL CLEVIS AND ON THE DISTAL CLEVIS, POSSIBLY THE LOCATION WHERE ENERGY TO ESCAPED. THE CHARRING ON THE PROXIMAL CLEVIS LINES UP CLOSELY WITH THE HOLE IN THE TIP COVER, HOWEVER, WITH THE WRIST PITCHED SLIGHTLY, THE HOLE MAY ALSO LINE UP WITH THE DISTAL CLEVIS CHAR SPOTS. DISTAL AND PROXIMAL CLEVIS DO NOT HAVE ANY ABNORMALLY SHARP EDGES THAT WOULD DAMAGE THE SILICONE. CABLES ARE NOT FRAYED AND ELECTRICAL CONTINUITY PASSED. NO OTHER DAMAGE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROCTECTOMY PROCEDURE, THE SURGEON SAW A PLUME OF ENERGY AND THEN SMOKE IN THE SURGICAL VIEW DUE TO BURNT PATIENT FAT. THE SURGEON IMMEDIATELY STOPPED THE SURGICAL TASK BEING PERFORMED AND REMOVED THE MONOPOLAR CURVED SCISSORS INSTRUMENT (MCS) AND INSPECTED THE MCS TIP COVER ACCESSORY, AT THAT TIME A HOLE IN THE MCS TIP COVER WAS NOTICED. THE MCS TIP COVER WAS REPLACED AND THE PLANNED PROCEDURE WAS COMPLETED. NO 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 C7333

    Patients

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