BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIRTCHER ESU PENCIL

    MDR report key: 200081 · Received December 1, 1998

    Report

    Report Number
    200081
    Event Type
    Injury
    Date Received
    December 1, 1998
    Date of Event
    September 28, 1998
    Report Date
    October 30, 1998
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING CORONARY ARTERY BYPASS GRAFT, PT REC'D A 3-5MM BURN TO LEFT THIGH FROM ESU PENCIL. BURN REQUIRED EXCISION IN THE OPERATING ROOM. TWO PENCILS WERE IN ONE UNIT AND WHEN THE FOOT PEDAL WAS PRESSED, THE HAND UNIT FIRED. MALFUNCTION WAS REPRODUCED IN BIOMED DEPT. UNIT SENT TO BIOTECH FOR REPLACEMENT OF DEFECTIVE MV RELAY AND HAND CONTROL JACKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIRTCHER ESU PENCIL ESU PENCIL GEI CONMED CORPORATION 5000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention