BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP RCKR PNCL BULKPAK

    MDR report key: 2214954 · Received August 8, 2011

    Report

    Report Number
    1717344-2011-00659
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Report Date
    July 11, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A SUPRACLAVICULAR LYMPH NODE BIOPSY PROCEDURE, FLAMING OCCURRED AT THE DEVICE TIP. NO PT INJURY OCCURRED. THE CUSTOMER REPORTED THAT OXYGEN WAS NOT IN USE. DUROPREP FOR THE NECK WAS USED, BUT ALLOWED TO THOROUGHLY DRY BEFORE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP RCKR PNCL BULKPAK ES ACCESSORY PENCIL GEI COVIDIEN LP (VALLEYLAB) 194909

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK (B)(4) COATED NEEDLE ELECTRODE, L/N UNK| (B)(4) NEEDLE ELECTRODE, L/N UNK