BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOLDLINE® PUSH BUTTON PENCIL

    MDR report key: 1911812 · Received December 1, 2010

    Report

    Report Number
    1720159-2010-00073
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K791137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) INSTRUCTIONS FOR USE CONTAINS THE FOLLOWING: SAFETY TIPS: NEVER ALLOW THE CABLE CONNECTED TO THESE DEVICES TO BE IN CONTACT WITH SKIN OF THE PATIENT OR OPERATOR DURING ELECTROSURGICAL ACTIVATIONS. ALWAYS PLACE UNUSED ASSOCIATED ELECTROSURGICAL ACCESSORIES IN A SAFE INSULATED LOCATION SUCH AS A HOLSTER WHEN NOT IN USE.

    Description of Event or Problem · 1

    NURSE WAS SCRUBBING FIELD AND HAD HER HAND OVER THE CORD OF THE PENCIL. PENCIL WAS IN THE HOLSTER. THERE WAS A RETRACTOR NEARBY AND NURSE DOESN'T REMEMBER IF SHE TOUCHED THE RETRACTOR, BUT FELT A SHOCK AND NOTICED A BURN HOLE THROUGH HER GOWN. NURSE MENTIONED THAT SHE RECEIVED A SUPERFICIAL BURN BUT WAS DOING FINE. SHE CLEANED UP THE BURN AND CONTINUED WORKING. PATIENT WAS FINE. PATIENT DID NOT RECEIVE ANY INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLDLINE® PUSH BUTTON PENCIL ELECTROSURGICAL PENCIL GEI CONMED ELECTROSURGERY UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other