BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 20CM

    MDR report key: 3252615 · Received July 15, 2013

    Report

    Report Number
    3006451981-2013-00231
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Report Date
    July 10, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PACKAGING OF THE DEVICE WAS DAMAGED. UPON RECEIPT AT COVIDIEN, A PRELIMINARY INVESTIGATION OF THE DEVICE FOUND THAT IT SELF-ACTIVATES WHEN PLUGGED INTO THE GENERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327680 LIGASURE ATLAS HANDSWITCHING 20CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S3A0001X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK