BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE IMPACT

    MDR report key: 1873112 · Received October 15, 2010

    Report

    Report Number
    1717344-2010-00712
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 21, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    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 DURING A GASTRECTOMY, THE DEVICE JAWS BECAME LOCKED ON ILEUM TISSUE AND WAS REMOVED BY THE SURGEON WITH GREAT FORCE. THE SURGEON EXTRACTED AN ADDITIONAL 20 CM OF THE ILEUM TO COMPLETE THE SURGERY. THE PATIENT IS REPORTED AS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 160331

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other