BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 20 CM

    MDR report key: 3150067 · Received May 21, 2013

    Report

    Report Number
    3006451981-2013-00162
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 25, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    UNKNOWN

    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 DEVICE WAS USED FOR AN OPEN HEMICOLECTOMY PROCEDURE. LARGE BUNDLES OF TISSUE WERE BEING SEALED AND CUT SUCCESSFULLY. THEN AFTER ANOTHER SEAL AND CUT, WHEN THE SURGEON OPENED THE DEVICE, THE JAW OF THE DEVICE WAS FOUND TO BE BROKEN. NOTHING FELL INTO THE PATIENT CAVITY. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY REPORTED. A PRELIMINARY EVALUATION OF THE DEVICE AT COVIDIEN HAS FOUND THAT A SMALL PIECE OF "AMODELE" IS MISSING FROM THE JAWS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223987 LIGASURE ATLAS HANDSWITCHING 20 CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2J0011X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK