BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLSEN MEDICAL ELECTROSURGICAL PENCIL

    MDR report key: 1815180 · Received August 12, 2010

    Report

    Report Number
    1530493-2010-00005
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Date of Event
    June 23, 2010
    Report Date
    August 11, 2010
    Manufacturer
    OLSEN MEDICAL
    Product Code
    GEI
    PMA / PMN Number
    K885200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIRMED BY PHONE ON (B)(4) 2010 THE EVENT AS DESCRIBED BY THE INITIAL REPORTER. END-USER DID NOT USE THE PROVIDED HOLSTER TO PLACE THE DEVICE IN WHEN NOT IN USE. THE DEVICE WAS DISCARDED AND NOT AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    EVENT DESC: PT HAD A CESAREAN SECTION. THE CAUTERY RELEASE BUTTON ON THE BOVIE PEN DID NOT RELEASE AND STAYED IN THE ON POSITION. THE PEN WAS PLACED ON THE DRAPE AND NOT IN THE HOLDER. THERE WAS A SMALL HOLE IN THE DRAPE INTO THE LEG SECURITY BELT. THE BURN DID NOT GO THROUGH THE BELT. THERE WAS NO INJURY TO THE PT. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLSEN MEDICAL ELECTROSURGICAL PENCIL SINGLE USE ELECTROSURGICAL PENCIL GEI OLSEN MEDICAL 75502 014885

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR NONE PER THE INITIAL REPORTER