BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 20 CM

    MDR report key: 1122265 · Received August 12, 2008

    Report

    Report Number
    1717344-2008-00368
    Event Type
    Malfunction
    Date Received
    August 12, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 16, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE DEVICE WAS USED FOR CYSTECTOMY/ILEAL CONDUIT. THE KNIFE WOULD NOT GO BACK TO THE ORIGINAL POSITION AND COULD NOT BE TAKEN OUT OF THE TISSUE. IT WAS ON ADIPOSE TISSUE AT THE TIME, SO FORCEPS AND ELECTRIC KNIFE WERE USED TO REMOVE THE DEVICE. THERE WAS SOME OOZING/BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 20 CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (US SURGICAL) N8E403K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK