BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX

    MDR report key: 3251511 · Received July 9, 2013

    Report

    Report Number
    3251511
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 23, 2013
    Manufacturer
    COVIDIEN FORMERLY VALLEY LAB
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, SURGEON WENT TO USE THE CAUTERY MACHINE AND THE TIP OF THE CAUTERY SPARKED. THERE WAS A BRIEF INSTANT OF FLAME AND A SIZZLING SOUND COULD BE HEARD. IT DID NOT TOUCH THE PATIENT, DRAPES OR ANYTHING ELSE. THE FLAME WAS DESCRIBED AS A "FLASH/AN INSTANT".MANUFACTURER RESPONSE FOR CAUTERY MACHINE, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================NONE AT THIS TIME.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?C-SECTION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314013 FORCE FX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN FORMERLY VALLEY LAB FORCE FX *

    Patients

    Seq Age Sex Outcome Treatment
    1 *