BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1232075 · Received November 7, 2008

    Report

    Report Number
    1717344-2008-00517
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. 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 DURING A COLECTOMY, THE DEVICE CUT BUT DIDN'T SEAL. THERE WAS BLEEDING AT THE GREATER OMENTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 37CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (US SURGICAL) N8G438

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK