BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 2091484 · Received May 6, 2011

    Report

    Report Number
    1717344-2011-00355
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 20, 2011
    Manufacturer
    COVIDIEN, LLC (SHANGHAI)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HAND PIECES DID NOT SEAL. THIS HAPPENED WITH TWO ATLAS HAND PIECES WITHIN THE SAME SURGERY. THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITH NO ISSUES. THE TWO DEVICES ARE ON MFR REPORT # 1717344-2011-00353.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN, LLC (SHANGHAI) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other FORCETRIAD - ENERGY PLATFORM - (B)(4)