BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 3063388 · Received March 28, 2013

    Report

    Report Number
    3006451981-2013-00082
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    February 14, 2013
    Report Date
    March 7, 2013
    Manufacturer
    COVIDIEN LLC (SHANGHAI)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) INDICATES THE LOT NUMBER WAS RELEASED MEETING ALL QA SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE DEVICE WAS IN USE, WHEN THE SURGEON WANTED TO OPEN THE JAWS, THE WHITE AMODELE PART ATTACHED TO THE METAL SEAL PLATE BROKE OFF AND FELL INTO THE PT'S ABDOMINAL CAVITY. THE AMODELE MATERIAL WAS REMOVED FROM THE PT CAVITY AND THE PT IS FINE. REPORTEDLY, THE DEVICE HAD NOT BEEN CLAMPED DOWN ON ANY HARD OBJECT, AND THE DEVICE HAD BEEN CLEANED FREQUENTLY DURING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127460 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LLC (SHANGHAI) S2J0012X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK