BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2963030 · Received January 24, 2013

    Report

    Report Number
    1717344-2013-00047
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 5, 2012
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN REC'D AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT DURING A RIGHT HEMICOLECTOMY, THE DEVICE WAS USED TO SEAL AND CUT TISSUE AND THE JAWS COULD NOT BE RE-OPENED FOR ANOTHER APPLICATION. THE SURGEON OPENED ANOTHER INSTRUMENT IN ORDER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY. THE DEVICE WAS RETURNED FOR EVALUATION WITH THE KNIFE BLADE EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34886 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 235738LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK