BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 2121497 · Received May 6, 2011

    Report

    Report Number
    1717344-2011-00339
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    COVIDIEN LP, (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE SURGERY, THERE WAS OOZING FROM THE SEAL AREA ALTHOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. THE SURGEON RESEALED OVER THE OOZING AREA TO CORRECT THE PROBLEM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP, (VALLEYLAB) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR