BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE LAPAROSCOPIC SLR/DIV

    MDR report key: 1032123 · Received April 16, 2008

    Report

    Report Number
    1717344-2008-00158
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 10, 2008
    Report Date
    March 20, 2008
    Manufacturer
    COVIDIEN LP, (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RETURNED. ADD'L QUESTIONS IN REGARD TO THE INCIDENT HAVE BEEN ASKED OF THE CUSTOMER. IF THE INCIDENT SAMPLE IS RETURNED OR ADD'L INFO PERTINENT TO THE INCIDENT IS REC'D, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE JAWS OF THE LIGASURE ATLAS WOULD NOT OPEN THE FIRST TIME THE DEVICE WAS APPLIED TO PT TISSUE. A LIGASURE V HANDPIECE WAS USED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE LAPAROSCOPIC SLR/DIV LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP, (US SURGICAL) N7E226

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK