BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 2082861 · Received April 29, 2011

    Report

    Report Number
    3006451981-2011-00054
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    January 28, 2011
    Report Date
    April 28, 2011
    Manufacturer
    COVIDIEN LLC, (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    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 DURING A GYNECOLOGICAL PROCEDURE THE LIGASURE WAS NOT OPENING AND CLOSING BEFORE USE ON THE PT. ANOTHER INSTRUMENT WAS USED TO PROCEED. AFTER RETURN AND BEGINNING INVESTIGATION, 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) S0C0038

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK