BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP PNCL W/HLSTR BULKPAK

    MDR report key: 1443386 · Received June 3, 2009

    Report

    Report Number
    1717344-2009-00257
    Event Type
    Malfunction
    Date Received
    June 3, 2009
    Date of Event
    April 7, 2009
    Report Date
    May 5, 2009
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). TESTING CONFIRMED THE PENCIL WAS SELF ACTIVATING WHEN PLUGGED IN. WHEN DISASSEMBLED INVESTIGATION FOUND THAT A SMALL METALLIC SHAVING WAS LODGED INSIDE THE BODY OF THE PENCIL CAUSING AN INTERMITTENT SHORT. MANUFACTURING TESTING WOULD NORMALLY DETECT THIS, BUT IT IS POSSIBLE THE INTERMITTENT NATURE OF THE FAULT PREVENTED THIS. A REVIEW DETERMINED THIS WAS AN ISOLATED OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RN OPENED THE PACKAGE AND PLUGGED THE PENCIL INTO THE GENERATOR. THE PENCIL WAS PLACED IN A HOLSTER. A BIPOLAR DEVICE (MANUFACTURER UNKNOWN) WAS ALSO PLACED IN THE HOLSTER AND THE CORD/PLUG OF THE BIPOLAR DEVICE THROWN OVER TO THE RN TO PLUG IN. AS THE RN TOOK THE CORD/PLUG OF THE BIPOLAR DEVICE, THE RN WAS BURNED & SHOCKED ON THE RIGHT HAND. THE RN THEN NOTICED THE PENCIL WAS ACTIVATING AND THE YELLOW BUTTON WAS STUCK ON. THE BURN WAS 1ST DEGREE OR LESS, NO TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP PNCL W/HLSTR BULKPAK ELECTROSURGICAL ACCESSORY GEI COVIDIEN LP (VALLEYLAB) 152655

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK