BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 1904172 · Received November 15, 2010

    Report

    Report Number
    1717344-2010-00853
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 10, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D, 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 DURING AN ABDOMINAL TUMOR RESECTION, THE JAWS OF THE DEVICE BECAME STUCK AND WOULD NOT OPEN. THE DEVICE WAS CUT OUT AND ANOTHER DEVICE WAS USED TO FINISH THE PROCEDURE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 193445L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK