BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE ADVANCE PISTOL GRIP

    MDR report key: 2082856 · Received April 29, 2011

    Report

    Report Number
    1717344-2011-00331
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 29, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE INSULATION SLEEVE ON THE DEVICE WAS TORN DURING SURGERY. THE INCIDENT DEVICE WAS RETURNED AND A VISUAL INSPECTION REVEALED THAT THE KNIFE WAS PROTRUDING FROM THE JAWS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE ADVANCE PISTOL GRIP LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 201603

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK