BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE LAPAROSCOPIC SLR/DIV

    MDR report key: 1071776 · Received July 7, 2008

    Report

    Report Number
    1717344-2008-00305
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    May 7, 2008
    Report Date
    June 9, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE RETURN OF THE INCIDENT SAMPLE HAS BEEN REQUESTED. TO DATE, IT HAS NOT BEEN RECEIVED FOR EVALUATION. ADDITIONAL QUESTIONS IN REGARD TO THE INCIDENT HAVE ALSO BEEN ASKED. 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 REPORT STATED THAT THE DEVICE WAS BEING USED ON THE UTERO-OVARIAN LIGAMENT. THE INSTRUMENT CUT, BUT DIDN'T SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE LAPAROSCOPIC SLR/DIV LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (US SURGICAL) N8A243

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK