BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2850179 · Received October 30, 2012

    Report

    Report Number
    1717344-2012-01137
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 17, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE 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 MEDWATCH RECEIVED STATED: DURING A CYSTECTOMY WITH ILEAL CONDUIT AND LOW ANTERIOR RESECTION CASE, THE DEVICE MALFUNCTIONED AND THE BLADE WENT TO A VERTICAL RATHER THAN A HORIZONTAL DIRECTION. THIS CAUSED LIGHT TISSUE TEARING BUT NO SIGNIFICANT OR PERMANENT DAMAGE. THE SURGEON OPENED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE SITE WAS CONTACTED AND ADDITIONAL INFORMATION REGARDING THE DEVICE AND INCIDENT WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 234118LX

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR