BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 37CM

    MDR report key: 1034053 · Received April 24, 2008

    Report

    Report Number
    1717344-2008-00161
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    February 5, 2008
    Report Date
    March 28, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. 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 HANDPIECE HAD A DEFECT ON THE WIRE AT THE JAWS. THE GREY WIRE WAS DAMAGED SO THAT YOU CAN SEE THE INSIDE OF THE WIRE.

    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) U7K40

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK