BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 3190782 · Received June 14, 2013

    Report

    Report Number
    1717344-2013-00422
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE UNIT WAS RETURNED TO AN INTERNATIONAL COVIDIEN SERVICE CENTER WHERE THE INVESTIGATION DID NOT IDENTIFY ANYTHING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE GENERATOR PASSED ALL THE TESTS AND FULFILLED ALL THE PARAMETERS SET BY THE MFR. THE INCIDENT CONCOMITANT MEDICAL PRODUCTS HRA5, LOT #3116X, AND E2100, LOT #215052X HAVE BEEN REQUESTED BUT TO DATE HAVE NOT BEEN RECEIVED FOR EVAL. IF THE SAMPLES ARE RECEIVED 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 AFTER PREPPING WITH THE DISINFECTANT SKINSEPT G WHICH CONTAINS ALCOHOL, THE DRAPES AND THE PT'S CHEST AND RIGHT ARM WERE IGNITED. THE INJURY WAS CLASSIFIED AS 1ST DEGREE BURN. THE PT WAS TREATED WITH CREAMS AND STERILE WOUND DRESSINGS AND WAS RELEASED FROM THE HOSP 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272182 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP FORCETRIAD

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR ELECTROCAUTERY PENCIL: LOT #215052X| COVIDIEN HRA5| RETURN ELECTRODE: LOT# 3116X, E2100