BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONMED SABRE 180

    MDR report key: 2132552 · Received June 9, 2011

    Report

    Report Number
    1720159-2011-00029
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    September 16, 2010
    Report Date
    June 9, 2011
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER-FACILITY SUSPECTS THAT THE ADVERSE EVENT TOOK PLACE BECAUSE THERE WAS A CALIBRATION ERROR WITHIN THE ELECTROSURGICAL UNIT (ESU). THE USER FACILITY ALSO STATED THAT THEY PURCHASED THE EQUIPMENT APPROXIMATELY IN (B)(6) 2009, AND THE OPERATOR'S MANUAL SUGGESTS THAT THE SABRE 180 SHOULD BE SUBJECT TO A PERFORMANCE TEST ANNUALLY. CONMED WAS NOT MADE AWARE OF ANY PREVENTIVE MAINTENANCE PERFORMED ON THE ESU. CONMED HAS NOT RECEIVED THE DEVICE IN QUESTION IN TIME TO REPORT THE EVAL FINDINGS. CONMED WILL FILE A F/U REPORT TO STATE OUR EVAL FINDINGS WITHIN THE NEXT 30 CALENDER DAYS.

    Description of Event or Problem · 1

    THE G.I DOCTOR WHO OPERATED THE UNIT MENTIONED THAT UPON USING THE UNIT, THE CURRENT DELIVERED DURING THE PROCEDURE PROVIDED A VERY LARGE PERIPHERAL EFFECT WHICH BURNED THE LINING OF THE PT. THE DOCTOR THEN PROCEEDED TO REDUCE THE POWER (IN WATTS) IN THE UNIT, BUT THE EFFECT DID NOT VARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONMED SABRE 180 ELECTROSURGICAL GENERATOR, PROD. CODE GEI GEI CONMED ELECTROSURGERY NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other| R