BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 2241572 · Received September 2, 2011

    Report

    Report Number
    1717344-2011-00789
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 30, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER A SEAL CYCLE, IT WAS NO LONGER POSSIBLE TO OPEN THE DEVICE. THE SURGERY WAS CONVERTED TO OPEN AND THE VESSEL WAS SUTURED IN ORDER TO REMOVE THE DEVICE. 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) 204135X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention