BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP PNCL W/HLSTR BULKPAK

    MDR report key: 3178988 · Received June 13, 2013

    Report

    Report Number
    1717344-2013-00418
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Report Date
    May 17, 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). TO DATE THE INCIDENT SAMPLE 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 CUSTOMER REPORTED THAT WHEN THE PENCIL WAS ACTIVATED, THE SURGICAL STAFF SAW FLAMES COMING FROM THE TIP OF THE ELECTRODE. THERE WAS NO INJURY TO THE PATIENT OR STAFF. A BLADE ELECTRODE WAS IN USE ALONG WITH A FORCEFXC GENERATOR SET AT 30-CUT AND 30-COAG. THE SITE BIOMED CHECKED THE INCIDENT GENERATOR AND FOUND IT TO FUNCTION PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268872 DISP PNCL W/HLSTR BULKPAK ES ACESSORY - NON STERILE GEI COVIDIEN LP UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FORCE FXC GENERATOR, S/N (B)(4)