BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 1060581 · Received June 9, 2008

    Report

    Report Number
    MW5007270
    Event Type
    Malfunction
    Date Received
    June 9, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 9, 2008
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE OPERATING ROOM HAS REPORTED TWO INSTANCES WHERE THE HANDSWITCHING ROCKER PENCIL'S ROCKER SWITCH CAP HAS "POPPED" OFF OF THE PENCIL. THE LOCATION OF THE PIECE AFTER POPPING COULD LAND ON THE FLOOR, ON A STERILE FIELD, OR IN THE PATIENT. IN EACH CASE THERE WAS NO PT INJURY, PROLONGATION OF THE PROCEDURE, OR ADVERSE EVENT REPORTED. THE OPERATING ROOM DIRECTOR INFORMED THE DISTRIBUTOR, THE MFR AND IMPLEMENTED STOP-GAP MEASURES INCLUDING NO LONGER USING THE CONMED PENCIL. THE DIRECTOR DESCRIBES THE PENCIL AS APPEARING THAT THE "FEET" ON THE ROCKER SWITCH ARE NOT SEALED TO THE PENCIL HOUSING. DIAGNOSIS OR REASON FOR USE: CAUTERY, CUTTING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED HANDSWITCHING ROCKER PENCIL GEI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other