BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENDEVAC W/COATED BLADE 10FT. TUBING HOLSTER

    MDR report key: 3963664 · Received March 6, 2014

    Report

    Report Number
    2320762-2014-00006
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    February 11, 2014
    Report Date
    March 6, 2014
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    GEI
    PMA / PMN Number
    K944265
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE INCIDENT REPORT, PRE-OPERATIVE THE HEALTH PERSONNEL OBSERVED A 3 CM FLAME FROM THE EXTENDEVAC ELECTROSURGICAL PENCIL. PREVIOUSLY THERE HAD BEEN PROBLEMS WITH THE RETURN ELECTRODE, WHICH "GLOWED RED." THE BURNER WAS USED TWICE SUBSEQUENTLY WITHOUT PROBLEMS. PACKAGING AND EQUIPMENT WERE UNFORTUNATELY NOT SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136252 EXTENDEVAC W/COATED BLADE 10FT. TUBING HOLSTER ELECTROSURGICAL, CUTTING & COAGULATI GEI DEROYAL INDUSTRIES, INC. 29722074

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention