BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2963045 · Received January 24, 2013

    Report

    Report Number
    1717344-2013-00045
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 17, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PANCREATICODUODENECTOMY, THE DEVICE WAS CONNECTED TO THE GENERATOR AND THE SURGEON HEARD A NOISE SIMILAR TO AN ACTIVATION TONES. THE SURGEON OPENED ANOTHER INSTRUMENT DUE TO THIS OCCURRENCE. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34736 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 232999LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK