BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX COOLCUT 90, ABLATOR

    MDR report key: 2882019 · Received December 20, 2012

    Report

    Report Number
    1220246-2012-00253
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    September 12, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ARTHREX, INC.
    Product Code
    GEI
    PMA / PMN Number
    K023996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS (AGE AT TIME OF EVENT, DATE OF BIRTH, GENDER, WEIGHT) WERE REQUESTED BUT NOT PROVIDED. NO FURTHER PATIENT INFORMATION WAS PROVIDED AT THE TIME OF THIS REPORT OR MADE AVAILABLE IN RESPONSE TO FOLLOW-UP COMMUNICATION. NO ADDITIONAL ADVERSE CONSEQUENCES HAVE BEEN REPORTED FROM THIS EVENT. THIS DEVICE IS USED FOR TREATMENT. THE COMPLAINT WAS NOT CONFIRMED. NO VISUAL INDICATION OF DAMAGE TO THE DEVICE. THE PROBE WAS TESTED USING AR-9600 OPES ELECTROSURGICAL GENERATOR. ALL THE BUTTONS OF THE DEVICE FUNCTIONED NORMALLY. CUSTOMER'S COMPLAINT CANNOT BE REPRODUCED. THE CAUSE OF THE EVENT CANNOT BE DETERMINED. THE COMPLAINANT'S EVENT DESCRIBES THE USE OF ANOTHER MANUFACTURER'S CONSOLE. THE DIRECTIONS FOR USE (DFU-0088) STATES THAT: "THE ARTHREX ABLATION PROBES ARE DESIGNED SPECIFICALLY FOR USE WITH AN ARTHREX OPES ELECTROSURGICAL GENERATOR. ARTHREX DOES NOT ASSUME RESPONSIBILITY FOR PROBLEMS THAT MAY OCCUR WHEN USING AN ARTHREX ABLATION PROBE WITH A THIRD PARTY GENERATOR. CERTAIN GENERATORS FROM OTHER MANUFACTURERS MAY ACCEPT THE ARTHREX ABLATION PROBE PIN CONNECTOR. IT IS THE RESPONSIBILITY OF THE USER FACILITY TO EVALUATE THIRD PARTY GENERATORS TO DETERMINE THE CORRECT OPERATING PARAMETERS AND POTENTIAL HAZARDS OF USING ARTHREX ABLATION PROBES WITH THESE GENERATORS. THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PART/SERIAL COMBINATION. THE POTENTIAL CAUSE(S) OF THIS EVENT WILL BE COMMUNICATED TO THE EVENT REPORTER. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY THE DEVICE REMAINED LOCKED IN CONTINUOUS COAGULATION MODE. THE NURSE WAS BURNT ON THE HAND WHEN DISCONNECTING THE DEVICE. DEVICE WAS USED WITH ANOTHER MANUFACTURER'S CONSOLE (COBY) AND RETURN ELECTRODE (COMEPA). MODE/POWER SETTING: COAG CUT. DUALWAVE PUMP USED. NO CANNULA USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTHREX COOLCUT 90, ABLATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ARTHREX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other