BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT THORACIC

    MDR report key: 2140601 · Received June 16, 2011

    Report

    Report Number
    1717344-2011-00491
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 15, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS BEING USED FOR EXCISION OF SARCOMA. IN USE, THE DEVICE JAWS BECAME JAMMED AND THE KNIFE WAS REPORTED AS PROTRUDING FROM THE JAWS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT THORACIC LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 206947LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK