BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 2082858 · Received April 29, 2011

    Report

    Report Number
    3006451981-2011-00036
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 7, 2011
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 ONE OF THE JAW WIRES WAS EXPOSED. THERE WAS NO PT INJURY. UPON RETURN AND EVAL, A BARE METAL WIRE WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) SOG0046

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK