BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE

    MDR report key: 1082356 · Received July 24, 2008

    Report

    Report Number
    1717344-2008-00341
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 30, 2008
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: 07/24/2008. TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR, IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE IFU STATES: CAREFULLY INSERT AND WITHDRAW INSTRUMENTS FROM CANNULAS TO AVOID POSSIBLE DAMAGE TO THE DEVICES AND/OR INJURY TO THE PT. TROCAR CANNULAS WITH HARD, NON-BEVELED OPENINGS MAY CAUSE THE FLEXIBLE INSULATION TO RETRACT, WHICH MAY COMPROMISE THE INSULATION. IF RETRACTION OCCURS, THE INSTRUMENT MUST BE DISCARDED. DO NOT INSERT THE INSTRUMENT DIRECTLY INTO A HAND-ASSIST PORT. DAMAGE TO THE FLEXIBLE INSULATION MAY OCCUR.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING LAPAROSCOPIC HYSTERECTOMY, THE SURGICAL TEAM WAS USING KARL STORZ REUSABLE PORTS, WHICH ARE KNOWN TO POTENTIALLY CAUSE HARM TO FLEXIBLE INSULATION. THE SURGEONS WERE TOLD OF POTENTIAL DAMAGE TO INSTRUMENT, BUT CHOSE TO CONTINUE USING THESE PORTS BECAUSE OF PRIOR SUCCESSES WITH THE DEVICE IN THIS TYPE OF PORT. UPON EXTRACTION FROM THE PORT, THE INSULATION WAS OBSERVED TO HAVE BEEN REMOVED FROM THE DEVICE AND HAD TO BE RETRIEVED FROM THE PT CAVITY. THERE WAS NO HARM TO THE PT AND ALL THE INSULATION WAS RETRIEVED. A SECOND INSTRUMENT WAS OPENED AND USED SUCCESSFULLY TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ADVANCE LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 135274

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FORCETRIAD ENERGY PLATFORM