BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE CT PEN ROCKER HLSTER GAYLD

    MDR report key: 3031289 · Received March 5, 2013

    Report

    Report Number
    1717344-2013-00157
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Report Date
    February 4, 2013
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL 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 A C-SECTION PROCEDURE, THEY EXPERIENCED SPARKS AND A FLAME FROM THE TIP OF THE PENCIL THAT WAS RECEIVED FROM ROI KIT PACKER. THE PENCIL WAS USED WITH A FORCEFXC GENERATOR WHICH WAS TESTED AT THE SITE AND FOUND TO FUNCTION PROPERLY. A MEGADYNE CAPACITOR PAD WAS ALSO IN USE. THERE WAS NO PT INJURY. THE INCIDENT SAMPLE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94774 EDGE CT PEN ROCKER HLSTER GAYLD ES ACCESSORY, NON-STERILE GEI COVIDIEN LP 235273X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MEGADYNE PAD, L/N UNKNOWN| FORCEFX GENERATOR, S/N UNKNOWN