BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONMED SYSTEM 2450

    MDR report key: 2151599 · Received June 29, 2011

    Report

    Report Number
    1720159-2011-00039
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 29, 2011
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INJURIES SUCH AS THE ONE REPORTED IN THIS MDR ARE CONSISTENT WITH ELECTROSURGICAL ACCESSORIES SUCH AS GROUNDING PADS AND CAUTERY PENCILS, BUT THEY ARE NOT CONSISTENT WITH GENERATORS. TO BE CONSERVATIVE AND CONSISTENT, CONMED IS REPORTING THIS ADVERSE EVENT WITH THE FDA.

    Description of Event or Problem · 1

    PROCEDURE: TONSILLECTOMY. AS THE NURSE TOUCHED THE BACK OF THE PT'S HAND, SHOCK WAS DELIVERED AND NURSE RECEIVED REDNESS ON HER FINGER, AND THE PT RECEIVED A MINOR BURN ON THE BACK OF HIS HAND. THE BURN WAS THE SIZE OF A PENCIL'S ERASER PER THE RISK MANAGER. THE BOY WAS GIVEN SILVADENE CREAM TO TREAT THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED SYSTEM 2450 ELECTROSURGICAL GENERATOR GEI CONMED ELECTROSURGERY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other MEGADYNE GROUNDING PAD| MEGADYNE CAUTERY PENCIL