BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGASURE IMPACT THORACIC

    MDR report key: 2940469 · Received December 19, 2012

    Report

    Report Number
    3006451981-2012-00257
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 14, 2012
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLE IS RECEIVED 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 AN ARM AMPUTATION, THE DEVICE JAWS WERE APPLIED TO MUSCULAR CANCER STATE TISSUE, THAT WAS DESCRIBED AS BEING VERY THICK, AND THE KNIFE BLADE CAME OFF THE TRACK WHILE CUTTING THE TISSUE. THE KNIFE IS REPORTED AS PROTRUDING FROM THE JAWS. THE SURGEON OPENED ANOTHER INSTRUMENT IN ORDER TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO BLOOD LOSS OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE IMPACT THORACIC LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN MEDICAL PRODUCTS SHANGHAI MANUFACTURING. LLC S2GF029X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK