BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1983227 · Received February 2, 2011

    Report

    Report Number
    3006451981-2010-00090
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    October 25, 2010
    Report Date
    January 11, 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 REC'D 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 AT THE END OF OPERATION, IT WAS NOTED THAT THE TIP OF THE INSULATION WAS DAMAGED. NOTHING FELL INSIDE THE PT CAVITY AND THERE WAS NO PT INJURY. UPON RETURN AN INITIAL VISUAL INSPECTION OF THE INCIDENT DEVICE IT WAS FOUND THAT IT HAD BARE JAW WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S0F0011

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK