BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP PNCL W/HLSTR BULKPAK

    MDR report key: 2973563 · Received February 13, 2013

    Report

    Report Number
    1717344-2013-00084
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 22, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE INCIDENT SAMPLE NOTED THE TIP WAS CHARRED. THE DEVICE WAS TESTED AND FOUND TO FUNCTION PROPERLY AND WITHIN SPECIFICATIONS. THE DEVICE INSTRUCTIONS FOR USE WARN THAT "BUZZING THE HEMOSTATS" (ACTIVATING THE DEVICE AGAINST A METAL OBJECT) IS NOT RECOMMENDED AND THE HAZARDS OF SUCH A PRACTICE CANNOT BE ELIMINATED. THE IFU PROVIDES INSTRUCTIONS TO HELP MINIMIZE THE RISK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SURGEON ACTIVATED THE HANDPIECE WHILE IT WAS UP AGAINST A HEMOSTAT WHILE BEING USED IN THE ABDOMINAL CAVITY AND IT IGNITED WITH A SMALL FLAME. THE DOCTOR BLEW THE FLAME OUT. THE DEVICE WAS EXCHANGED AND THE CASE CONTINUED WITHOUT INCIDENT. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64252 DISP PNCL W/HLSTR BULKPAK ES ACCESSORY - NON STERILE GEI COVIDIEN LP 240136X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK