BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE XTD ELECTRODE

    MDR report key: 725476 · Received June 12, 2006

    Report

    Report Number
    1717344-2006-00176
    Event Type
    Injury
    Date Received
    June 12, 2006
    Date of Event
    May 21, 2006
    Report Date
    June 2, 2006
    Manufacturer
    VALLEY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USS REFERENCE: 200606-0083. INITIAL REPORT SENT: 6/12/2006

    Description of Event or Problem · 1

    THE SURGEON ENCOUNTERED EXCESSIVE POST PROCEDURE BLEEDING WHEN USING THE LIGASURE* SYSTEM ON EXTERNAL HEMORRHOIDS. THE CASE IN QUESTION IS A 6 DAY POST PROCEDURE BLEED THAT REQUIRED 2 UNITS OF BLOOD TRANSFUSION. THE APEX OF THE LEFT LATERAL QUANDRANT 1 INCH ABOVE THE ANAL VERGE WHERE LIGASURE* WAS APPLIED WAS COMPLETELY OPEN APPROXIMATELY 1 INCH IN SIZE. THE SURGEON SUTURED THE DEFECT CLOSED. IN THE RIGHT POSTERIOR QUANDRANT THERE WAS AN OPEN SEAL WHERE LIGASURE* HAD BEEN APPLIED APPROXIMATELY 1 INCH IN SIZE. THIS WAS ALSO SUTURED CLOSED. PROCEDURE: HEMORRHOIDECTOMY 3 QUANDRANTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE XTD ELECTRODE ELECTROSURGICAL DEVICE GEI VALLEY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other