BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCE FX

    MDR report key: 5271307 · Received December 7, 2015

    Report

    Report Number
    3006451981-2015-00294
    Event Type
    Malfunction
    Date Received
    December 7, 2015
    Date of Event
    May 14, 2012
    Report Date
    November 13, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN REFERENCE # : (B)(4). TO DATE THE UNIT HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT A FORCE FX GENERATOR WAS IN USE IN (B)(6) 2012 WHEN SHE HAD A CERVIX CONIZATION, AND DURING THE PROCEDURE SHE RECEIVED A SECOND DEGREE BURN TO HER LEG IN THE AREA THAT THE RETURN ELECTRODE HAD BEEN PLACED. THE MANUFACTURER OF THE RETURN ELECTRODE WAS NOT IDENTIFIED. THE BURNED AREA WAS CLEANED, SANITIZED, WASHED WITH STERILE PHYSIOLOGIC SOLUTION AND A BANDAGE WAS APPLIED TO THE AFFECTED AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800439 FORCE FX ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR