BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS20CM

    MDR report key: 1000534 · Received February 11, 2008

    Report

    Report Number
    1219930-2008-00115
    Event Type
    Malfunction
    Date Received
    February 11, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 16, 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 11, 2008. THE RETURNED OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A COLECTOMY THE LIGASURE ATLAS WAS BEING USED TO SEAL AND TRANSECT TISSUE IN THE MESENTERY. AFTER APPROXIMATELY 10 COMPLETE SEALING CYCLES, UNDER 200CC'S OF BLEEDING OCCURRED FROM THE SEALED TISSUE. THE TISSUE WAS THICK, SO THE BLEEDING DID NOT STOP EVEN THOUGH THE TISSUE WAS DIVIDED INTO A FEW LAYERS AND SEALED. THE BLEEDING AREA WAS THEN MANUALLY SUTURED. THE POWER OF THE GENERATOR WAS THEN RAISED TO LEVEL 3 AND THE OPERATION WAS COMPLETED WITHOUT ANY FURTHER PROBLEMS. THE PT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS20CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (US SURGICAL) N7F287

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK