BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1854345 · Received September 29, 2010

    Report

    Report Number
    1717344-2010-00650
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 13, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 REPORTED THAT THE DEVICE JAMMED DURING USE. THERE WAS NO PT INJURY INVOLVED. WHEN THE SAMPLE WAS RETURNED FOR EVAL IT WAS NOTED THAT THE KNIFE WAS PROTRUDING FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 172180

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK