BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ATLAS HANDSWITCHING 20CM

    MDR report key: 1003732 · Received February 20, 2008

    Report

    Report Number
    1219930-2008-00150
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 24, 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 ALSO BEEN ASKED OF 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 DURING A GASTRECTOMY, THE LIGASURE ATLAS WAS ACTIVATED THROUGH A FULL SEALING CYCLE WITH AN END TONE. THE SURGEON STATED THAT THE DEVICE DID NOT COAGULATE THE PATIENT'S TISSUE. ANOTHER LIGASURE ATLAS WAS THEN OPENED AND USED FOR THE PROCEDURE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ATLAS HANDSWITCHING 20CM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (US SURGICAL) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK