BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2123598 · Received June 10, 2011

    Report

    Report Number
    1717344-2011-00462
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 8, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. 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 AFTER FIVE APPLICATIONS, THE DEVICE JAWS BECAME JAMMED. IT WAS REPORTED THAT THE DEVICE HAS AN EXPOSED KNIFE. ADDITIONAL QUESTIONS HAVE BEEN ASKED REGARDING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 199213L

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK