BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 3980684 · Received June 20, 2014

    Report

    Report Number
    1717344-2014-00532
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 28, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A NEPHRECTOMY, AFTER SOME TIME OF SEALING, THE JAWS WOULD NOT REOPEN AFTER THE PT TISSUE HAD BEEN SEALED AND CUT. THE SURGEON WAS ABLE TO FORCE THE JAWS OPEN BY USING BOTH HANDS. THERE WAS NO PT HARM. UPON RECEIPT OF THE DEVICE FOR EVAL AT COVIDIEN, A PRELIMINARY INVESTIGATION FOUND THAT THE KNIFE BLADE WAS PROTRUDING FROM THE JAWS OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364271 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK