BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE V 5 MM SEALER DIVIDER

    MDR report key: 2023744 · Received February 15, 2011

    Report

    Report Number
    1717344-2011-00096
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    January 15, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT: (B)(4) 2011. THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVALUATION. IF THE SAMPLE IS REC'D OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER THE SECOND ACTIVATION, THE KNIFE WAS OUTSIDE THE JAW TRACK. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE V 5 MM SEALER DIVIDER LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 135029

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening