BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT

    MDR report key: 2962988 · Received January 23, 2013

    Report

    Report Number
    1717344-2013-00044
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 18, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. 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 WHILE THE SURGEON WAS WORKING ON AN UPPER ABDOMINAL TUMOR, THE DEVICE JAWS COULD NOT BE RE-OPENED. THE SURGEON RESECTED THE TISSUE DIRECTLY ADJACENT TO THE DEVICE JAWS IN ORDER TO REMOVE THEM. THE DEVICE KNIFE IS REPORTED AS PROTRUDING FROM THE JAWS. THE SURGEON OPENED ANOTHER TYPE OF LIGASURE DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33328 LIGASURE IMPACT LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP 213433LX

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK