BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 3072904 · Received April 5, 2013

    Report

    Report Number
    1717344-2013-00259
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 15, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NO LONGER OPEN WHILE ON TISSUE BUT WAS REMOVED MANUALLY. THE DEVICE ALSO STOPPED ACTIVATING AND WAS NOT RESPONDING TO THE SURGEON DEPRESSING THE ACTIVATION SWITCH. IT WAS REPORTED THAT THE PT WAS BLEEDING AND THIS WAS TREATED WITH CLAMPS. IT IS UNK WHAT CAUSED THE BLEEDING. THIS HAPPENED 1 MINUTE INTO THE CASE, WHICH WAS COMPLETED WITH ANOTHER DEVICE. THE PT IS REPORTED TO HAVE RECOVERED. THERE IS NO FURTHER CUSTOMER INFO AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141758 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 228165X

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR