BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 1854371 · Received September 29, 2010

    Report

    Report Number
    1717344-2010-00675
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 6, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE #: (B)(6). DATE OF INITIAL REPORT: (B)(6) 2010. THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A GASTRECTOMY, OOZING UNDER 200CC OCCURRED ALTHOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 187359

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Life Threatening