BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS20CM

    MDR report key: 1003734 · Received February 20, 2008

    Report

    Report Number
    1219930-2008-00141
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 21, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT: FEBRUARY 20, 2008. THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS HAVE BEEN ASKED ON THE CUSTOMER. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT THE LIGASURE ATLAS WAS BEING USED IN A PROCEDURE ON THE COLON/ILEUS. AFTER SOME USE, THE JAWS OF THE DEVICE WOULD NOT OPEN. THE SURGEON WAS ABLE TO REMOVE THE DEVICE FROM THE TISSUE BY FORCE. THIS CAUSED BLOOD LOSS OF LESS THAN 200 CC'S. ANOTHER LIGASURE ATLAS HANDPIECE WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS20CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (US SURGICAL) N7J297

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK