BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONMED

    MDR report key: 852678 · Received May 18, 2007

    Report

    Report Number
    1720159-2007-00024
    Event Type
    Other
    Date Received
    May 18, 2007
    Date of Event
    April 10, 2007
    Report Date
    May 10, 2007
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXCALIBUR PLUS PC (ABOUT ONE YR OLD) WAS USED WITH THE PENCIL DURING THE PROCEDURE. THE BIOMED DEPT AT HOSP THOROUGHLY EVALUATED THE ESU AND FOUND THE DEVICE TO OPERATE WITHIN ALL SPECS, NO PROBLEMS FOUND. THE EXCALIBUR PLUS PC WAS NOT RETURNED FOR EVAL. HOWEVER, THE PENCIL USED DURING THE INCIDENT WAS RETURNED. THIS PENCIL IS A CONCOMITANT DEVICE TO THE GROUNDING PAD WHERE THE ALLEGED BURN TOOK PLACE. THE GROUNDING PAD REPORT/DATA COLLECTION IS BEING HANDLED BY CONMED CORPORATE.

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE PT WAS LIGHTLY BURNED ON BACK OF THIGH, LEAVING A SMALL RED MARK AT THE GROUNDING PAD SITE. AN EXCALIBUR PLUS PC (ABOUT ONE YR OL) WAS USED WITH THE PENCIL DURING THE PROCEDURE. THE BIOMED DEPT AT HOSP THOROUGHLY EVALUATED THE ESU AND FOUND THE DEVICE TO OPERATE WITHIN ALL SPECS, NO PROBLEMS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED ESP-BUTTON, W/ ULTRACLEAN GEI CONMED ELECTROSURGERY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other