BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 3981196 · Received July 23, 2014

    Report

    Report Number
    3006451981-2014-00688
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    COVIDIEN MEDICAL , LLC (SHANGHAI)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: 07/23/2014. 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 HAD REPORTED THAT THE DEVICE COULD NOT BE CLOSED AND THERE WAS NO HARM TO THE PATIENT. UPON RECEIPT OF THE DEVICE FOR EVALUATION AT COVIDIEN, A PRELIMINARY INVESTIGATION FOUND THAT BOTH OF THE GRAY JAW WIRES WERE BARE, AND THE INSULATION WAS MISSING FROM BOTH WIRES. THE MISSING PIECES OF INSULATION WERE NOT RETURNED. THE CUSTOMER WAS NOTIFIED OF THE MISSING INSULATION DUE TO THE POSSIBILITY THAT THE MISSING INSULATION COULD HAVE FALLEN INTO THE PATIENT CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432439 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN MEDICAL , LLC (SHANGHAI) S1A0013

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other