BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE IMPACT

    MDR report key: 1853334 · Received September 30, 2010

    Report

    Report Number
    1717344-2010-00677
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 24, 2010
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SITE INDICATED THAT THE INCIDENT SAMPLE WAS DISCARDED. IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY PERFORMED HEMIGASTRECTOMY BILLROTH II PROCEDURE ON A PT WITH NO ABNORMAL OCCURRENCES NOTED DURING THE SURGERY. THE PT INCURRED POSTOPERATIVE BLEEDING SEVERAL DAYS AFTER SURGERY. AN ADDITIONAL SURGERY WAS PERFORMED, AND THE SURGEON USED LIGATION TO SEAL THE VESSEL. THE CUSTOMER HAS INDICATED THAT THE HANDPIECE FOR THIS INCIDENT HAS BEEN DISCARDED. THE PT 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) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R FORCE TRIAD ENERGY PLATFORM