BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION COAGULATOR

    MDR report key: 3231181 · Received July 2, 2013

    Report

    Report Number
    3231181
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 22, 2013
    Report Date
    July 2, 2013
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT THE END OF THE PROCEDURE DURING REMOVAL OF COAGULATOR FROM ESU (ELECTROSURGICAL UNIT) THE END OF HAND PIECE WAS CHARRED GOING INTO TO THE ADAPTOR. NO PATIENT OR STAFF INJURY. NO CHARRING ON DRAPES OR ANY OTHER PART OF THE SURGICAL FIELD/EQUIPMENT. THERE WAS NO SURGICAL FIRE OR INDICATIONS OF ONE; BUT THE CONCERN IS THAT THE EVENT COULD HAVE RESULTED IN A SURGICAL FIRE. THERE ALARM ON UNIT DID NOT SOUND OR GO OFF.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?TONSILECTOMY AND POSSIBLE ADENOIDECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300778 SUCTION COAGULATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI CONMED CORPORATION * 12MHL0002

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR INSTRUMENTS FOR SURGICAL PROCEDURE