BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE PRECISE+

    MDR report key: 3222153 · Received July 2, 2013

    Report

    Report Number
    1717344-2013-00486
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 7, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. 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 CUSTOMER REPORTED THAT TWO DEVICES, PLUGGED INTO THE SAME GENERATOR, WERE PROVIDING INTERMITTENT OUTPUT AND WERE NOT SEALING PROPERLY. ALTHOUGH AN END TONE, INDICATING A COMPLETED SEAL CYCLE, WAS HEARD, THE SURGEONS COULD NOT TELL WHICH DEVICE IT CAME FROM. THERE WAS NO DELAY IN SURGERY AND NO PATIENT INJURY. THE SURGERY WAS COMPLETED WITH THE TWO DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300863 LIGASURE PRECISE+ LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK