BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONMED SYSTEM 2450

    MDR report key: 2071833 · Received April 21, 2011

    Report

    Report Number
    1720159-2011-00018
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 14, 2011
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE EVENT, AN INITIAL TEST WAS CONDUCTED ON-SITE TO CONFIRM THAT LEAKAGE CURRENT WAS NOT THE CAUSE AND SUGGESTS THE CAUSE TO BE SURGICAL TECHNIQUE. CONMED LINVATEC (B)(4) CONDUCTED AN IN-SERVICE AT (B)(6) HOSPITAL WHEN THIS HOSPITAL PURCHASED THEIR SYSTEM 2450. ADDITIONAL IN-SERVICE VISITS HAVE ALSO BEEN CONDUCTED IN THE LAST 12 MONTHS. A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA FOLLOWING EVALUATION OF THE RETURNED DEVICE AND DIATHERMY PENCIL. THE OPERATOR'S MANUAL FOR THE SYSTEM 2450 PROVIDES A COMPREHENSIVE SERIES OF CAUTIONS, INCLUDING: "1.1 SAFE AND EFFECTIVE ELECTROSURGERY IS DEPENDENT NOT ONLY ON EQUIPMENT DESIGN, BUT ALSO ON FACTORS UNDER THE CONTROL OF THE OPERATOR. IT IS IMPORTANT THAT THE INSTRUCTIONS SUPPLIED WITH THIS EQUIPMENT BE READ, UNDERSTOOD AND FOLLOWED IN ORDER TO ENSURE SAFE AND EFFECTIVE USE OF THE EQUIPMENT." CAUTIONS ARE THEN PROVIDED FOR EQUIPMENT PREPARATION (OPERATOR'S MANUAL SECTION 1.1.1), PATIENT PREPARATION (1.1.2), FOR USE (1.1.3), AS WELL AS FOR TESTING AND SERVICING (1.1.4). SECTION 1.1.3 (CAUTIONS FOR USE) PROVIDES WARNINGS, INCLUDING BURNS TO THE PATIENT OR OPERATOR.

    Description of Event or Problem · 1

    THE DOCTOR HAD BURNT HIMSELF WHILE OPERATING. THE DOCTOR REPORTED THE HE SUSTAINED A 2 MM BURN THROUGH THE GLOVE USING "DEBAKEY" FORCEPS. THESE FORCEPS DO NOT HAVE A CENTRALISED LOCATING PIN AS GILLES FORCEPS. DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED SYSTEM 2450 ELECTROSURGICAL GENERATOR, PROD. CODE GEI GEI CONMED ELECTROSURGERY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other