BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT THORACIC

    MDR report key: 2894303 · Received November 16, 2012

    Report

    Report Number
    1717344-2012-01173
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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 REPORTED THAT DURING A PELVIC EXENTERATION, THE KNIFE BLADE DID NOT RETRACT AND WAS CONTAINED WITHIN THE JAWS. THE DEVICE WAS REMOVED WITH NO TISSUE DAMAGE OR PT INJURY. ANOTHER INSTRUMENT WAS UTILIZED TO CONTINUE THE PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION WITH THE KNIFE BLADE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT THORACIC LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 228488LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK