BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 1821583 · Received August 27, 2010

    Report

    Report Number
    1717344-2010-00593
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 30, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE WAS RETURNED, EVALUATED AND FOUND TO FUNCTION WITHIN SPECIFICATION. ADDITIONAL TESTING WAS DONE BY PERFORMING MULTIPLE SEALS OF VARIOUS SIZES ON PORCINE TISSUE AND ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A GASTRIC BYPASS, OOZING OCCURRED ALTHOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 185586

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK