BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE LAPAROSCOPIC SLR/DIV

    MDR report key: 725112 · Received June 8, 2006

    Report

    Report Number
    1717344-2006-00177
    Event Type
    Malfunction
    Date Received
    June 8, 2006
    Date of Event
    May 16, 2006
    Report Date
    May 18, 2006
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USS REFERENCE: 200606-0354. INITIAL REPORT SENT: 06/08/2006.

    Description of Event or Problem · 1

    PROCEDURE: SPLEENECTOMY. REPORTEDLY, THE SURGEON ACTIVATED THE DEVICE AND FELT THE COAGULATING TIME WAS SHORTER THAN USUAL, BUT COMPLETION TONE SOUNDED . HE THEREFORE CUT THE TISSUE WHICH RESULTED IN SMALL BLOOD LOSS. THE PROCEDURE WAS COMPLETED WITH ANOTHER LS1100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE LAPAROSCOPIC SLR/DIV ELECTROSURGICAL DEVICE GEI VALLEYLAB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR