BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE V SEALER/DIVIDER

    MDR report key: 982249 · Received January 15, 2008

    Report

    Report Number
    1717344-2008-00015
    Event Type
    Injury
    Date Received
    January 15, 2008
    Date of Event
    November 9, 2007
    Report Date
    January 7, 2008
    Manufacturer
    COVIDIEN LP, (VALLEYLAB)
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. COVIDIEN LP (FORMERLY VALLEYLAB) HAS REQUESTED ADDITIONAL INFO FROM THE SITE. THE SITE HAS NOT RESPONDED. 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 THE PT'S TISSUE STUCK TO THE LIGASURE INSTRUMENT. THE SURGEON COULD NOT OPEN THE JAWS OF THE INSTRUMENT. THE PT HAD TO BE RE-OPERATED UPON BECAUSE OF BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V SEALER/DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP, (VALLEYLAB) 129405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention