BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYFRECATOR 2000

    MDR report key: 3103025 · Received May 9, 2013

    Report

    Report Number
    1720159-2013-00049
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    CONMED ELECTROSURGERY
    Product Code
    GEI
    PMA / PMN Number
    K970493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION, THE HYFRECATOR 2000, IS AN ELECTROSURGICAL UNIT (ESU) THAT PROVIDES BOTH MONOPOLAR AND BIPOLAR MODES FOR USE IN A VARIETY OF PROCEDURES WHERE ELECTROSURGICAL DESICCATION, FULGURATION, AND/OR COAGULATION IS NEEDED. THE DESCRIPTION OF THE INCIDENT GIVEN BY THE END-USER READS: "DURING PROCEDURE PENCIL WIRE CAUGHT ON FIRE ON TOP OF THE UNIT. NO FURTHER INFORMATION AVAILABLE REGARDING INCIDENT". THE HYFRECATOR UNIT WAS EVALUATED AT OUR CONMED, (B)(4) FACILITY. THE UNIT WAS RECEIVED BURNT AT PENCIL PORT. THE PENCIL WAS RETURNED BUT NO CORD RETURNED WITH THE PENCIL. THE HYFRECATOR UNIT WAS EVALUATED AND FOUND TO BE FUNCTIONING AS EXPECTED, TESTING WITHIN SPECIFICATIONS. THE TOP COVER WAS DAMAGED DUE TO THE FIRE AND WAS REPLACED. THE PENCIL WAS RETURNED BROKEN AND UNABLE TO BE TESTED. THE PENCIL WAS REPLACED WITH A NEW HYFRECATOR PENCIL. THE HYFRECATOR 2000, OPERATOR'S MANUAL STATES THAT, "SAFE AND EFFECTIVE ELECTROSURGERY IS DEPENDENT NOT ONLY ON EQUIPMENT DESIGN, BUT ALSO ON FACTORS UNDER CONTROL OF THE OPERATOR. IT IS IMPORTANT THE INSTRUCTIONS SUPPLIED WITH THIS EQUIPMENT BE READ, UNDERSTOOD, AND FOLLOWED IN ORDER TO ENSURE SAFE AND EFFECTIVE USE OF THE EQUIPMENT". THE OPERATOR MANUAL ALSO STATES IN SECTION 1 - INSPECTION: "REGULARLY INSPECT ACCESSORIES FOR DAMAGE, IN PARTICULAR, ELECTRODE CABLES AND ENDOSCOPICALLY USED ACCESSORIES SHOULD BE CHECKED FOR POSSIBLE DAMAGE TO THE INSULATION". POSSIBLE CAUSE OF THIS REPORTED INCIDENT COULD BE A PENCIL CORD WHERE THE INSULATION WAS BROKEN OR CRACKED, AND, ON ACTIVATION CAUSED THE CORD TO CATCH FIRE. WITH THE CORD NOT BEING RETURNED THIS COMPLAINT IS INCONCLUSIVE AND ROOT CAUSE CAN NOT BE DETERMINED. NO MANUFACTURING RELATED DEFECT WAS OBSERVED DURING THE INVESTIGATION; THEREFORE, NO CORRECTIVE ACTION IS RECOMMENDED AT THIS TIME. CONMED IS CONSIDERING THIS COMPLAINT CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED, "DURING PROCEDURE PENCIL WIRE CAUGHT ON FIRE ON TOP OF THE UNIT. (B)(6) DIDN'T HAVE ANY FURTHER INFORMATION ON INCIDENT". IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT OR END-USER INJURY ASSOCIATED WITH THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204602 HYFRECATOR 2000 HYFRECATOR ESU GEI CONMED ELECTROSURGERY N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other