BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 1953914 · Received December 15, 2010

    Report

    Report Number
    1717344-2010-00947
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 16, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 REPORTED THAT DURING A HYSTERECTOMY, THE DEVICE BLADE JAMMED AND THE JAWS WOULD NO LONGER OPEN. ADD'L RESECTION WAS PERFORMED TO REMOVE THE DEVICE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 194549

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK