BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 2233230 · Received August 29, 2011

    Report

    Report Number
    2233230
    Date Received
    August 29, 2011
    Date of Event
    April 27, 2011
    Report Date
    August 29, 2011
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE NEEDLE TIP WITH THE ELECTROSURGICAL HANDPIECE DURING THE PROCEDURE; BRAND: CONMED., REF# 138105, LOT # 110114. THE HANDPIECE WAS PLUGGED INTO THE ARGON BEAM UNIT AND THE SETTINGS WERE FOR COAGULATION AND CUT, SET TO 40/40 AND ON BLEND. THE NEEDLE TIP WAS FOUND TO BE MELTED AFTER USE BY THE SURGEON. BIOMED ENGINEERING WAS INFORMED AND CAME TO INSPECT THE NEEDLE TIP AND ARGON BEAM ELECTROSURGICAL GENERATOR. BIOMED EVALUATED THE ARGON BEAM MACHINE AND FOUND IT TO BE IN PROPER WORKING FUNCTION. BIOMED DETERMINED THAT THE CURRENT SETTINGS USED FOR THIS HANDPIECE NEEDLE TIP EXCEEDED RECOMMENDED SETTINGS OF 25 W. SETTINGS AS NOTED WERE 40/40. COMMUNICATION TO ALL SURGEONS BY THE SURGICAL QA CHAIR REGARDED THE PROPER SETTINGS INTENDED FOR THE SPECIFIC NEEDLE TIP. THERE IS NO INDICATION ON THE NEEDLE TIP PACKAGING TO INDICATE THE PROPER SETTINGS FOR THE GENERATOR. NOR ARE THERE RECOMMENDATIONS FROM CONMED AS TO SPECIFIC SETTINGS FOR SPECIFIC NEEDLE TIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED CORPORATION * 110114

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR