BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT THORACIC

    MDR report key: 2221479 · Received August 17, 2011

    Report

    Report Number
    1717344-2011-00709
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 25, 2011
    Report Date
    August 2, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE USE OF THE INSTRUMENT, THE SURGEON WAS ABLE TO OPEN THE JAWS OF THE DEVICE WHILE THE KNIFE WAS ADVANCED. THE INSTRUMENT WAS NOT ON TISSUE WHEN THIS OCCURRED AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT THORACIC LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 208666LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK