BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2220038 · Received August 12, 2011

    Report

    Report Number
    1717344-2011-00682
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 26, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THE DEVICE JAWS BECAME LOCKED AND WOULD NOT CUT DURING A LAPAROSCOPIC PROCEDURE. THERE WAS NO PATIENT INJURY. 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 IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 210429LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK