BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE LAPAROSCOPIC SLR/DIV

    MDR report key: 1012814 · Received March 12, 2008

    Report

    Report Number
    1717344-2008-00076
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 12, 2008
    Manufacturer
    COVIDIEN LP (US SURGICAL)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE INCIDENT DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY THE LIGASURE ATLAS HANDPIECE WAS USED TO SEAL AND TRANSECT TISSUE. AFTER USE ON ONE OF THE UTERINE LIGAMENTS THE DEVICE WOULD NOT OPEN TO RELEASE THE PT TISSUE. THE TISSUE WAS DISSECTED AROUND THE DEVICE TO REMOVE IT. THIS DID NOT CAUSE ANY EXTRA INJURY FOR THE PT.

    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) N7C112

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK LIGASURE8 SYSTEM GENERATOR| S/N UNKNOWN