BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS20CM

    MDR report key: 1003735 · Received February 20, 2008

    Report

    Report Number
    1219930-2008-00142
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 18, 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 INCIDENT SAMPLE WAS REPORTED TO BE DISCARDED BY THE SITE AND IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL QUESTIONS HAVE BEEN ASKED OF THE CUSTOMER. 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 AN ESOPHAGECTOMY. FROM THE BEGINNING OF THE PROCEDURE, THE SURGEON EXPERIENCED TISSUE STICKING OF THE TIP OF THE JAWS. ANOTHER LIGASURE ATLAS WAS OPENED AND USED FOR THE PROCEDURE. THE PATIENT EXPERIENCED SOME OOZING BLEEDING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK