BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E9000 HIGH SPEED DRILL

    MDR report key: 3132777 · Received May 29, 2013

    Report

    Report Number
    1017294-2013-00021
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 29, 2013
    Manufacturer
    CONMED LINVATEC
    Product Code
    HRX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION AND TESTING OF THE RETURNED E9000 HIGH SPEED DRILL FOUND THE UNIT WAS RECEIVED INOPERABLE DUE TO A FROZEN MOTOR. TESTING FOUND THE BUR WAS NOT TURNING DUE TO MOTOR FAILURE. IN THIS INSTANCE, A FROZEN MOTOR COULD LEAD TO MOTOR BINDING, HEATING, AND SEIZED OPERATION. DUE TO THE INOPERABLE CONDITION OF THE RETURNED HANDPIECE, FURTHER TESTING TO DUPLICATE THE REPORTED PROBLEM OF "OVERHEATING" COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY INDICATED THAT THE HANDPIECE WAS MANUFACTURED ON DECEMBER 15, 2011 WITH THE LAST SERVICE REPAIR DATE OF (B)(6) 2013. DURING THIS SERVICE, PM WAS PERFORMED AND THE MOTOR AND VARIOUS COMPONENTS WERE REPLACED AT THAT TIME. IT IS NOT KNOWN IF CONTINUOUS IRRIGATION WAS BEING USED WHEN THE DEVICE BECAME "OVERHEATED" AND NONFUNCTIONAL, BUT COOLING FOR THE E9010 BODY IS RECOMMENDED AT ALL TIMES. WHEN USING THE E9414 TUBING SET, THE TUBING LINE MUST BE FULLY PRIMED OR THE E9010 WILL OVERHEAT. THE INVOLVED BUR/BLADE WAS NOT RETURNED FOR EVALUATION. TO REDUCE THE RISK OF DEVICE OVERHEATING AND INJURY TO THE PATIENT, THE INSTRUCTION FOR USE (IFU) PROVIDES THE FOLLOWING PRECAUTIONS: INSPECT ALL EQUIPMENT FOR PROPER OPERATION. ENSURE ALL ATTACHMENTS AND ACCESSORIES ARE CORRECTLY AND COMPLETELY ATTACHED TO THE HANDPIECE. PERFORM THE REQUIRED PERFORMANCE TESTS FOR EACH ASSOCIATED HANDPIECE PRIOR TO EACH USE. CONTINUALLY CHECK ALL HANDPIECES AND ATTACHMENTS FOR OVERHEATING. IF OVERHEATING IS SENSED, IMMEDIATELY DISCONTINUE USE AND RETURN EQUIPMENT FOR SERVICE. OVERHEATING OF THE BUR, BIT OR BLADE MAY CAUSE DAMAGE TO THE BUR, BIT OR BLADE AND MAY CAUSE THERMAL NECROSIS. AN EDUCATION LETTER WILL BE SENT TO THE CUSTOMER WITH THE EVALUATION RESULTS AND TO REITERATE THE IMPORTANCE OF USING CONTINUOUS IRRIGATION AND MONITORING FOR HEAT DURING USE AS WELL AS PROPER CARE AND HANDLING OF THE HANDPIECES AND ATTACHMENTS.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE HAS NOT BEEN RETURNED FROM THE USER FACILITY FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING USE OF THIS E9000 HIGH SPEED DRILL IN A MASTOIDECTOMY PROCEDURE ON (B)(6) 2013, THE USER NOTICED THAT THE BURR WAS NOT TURNING AND THE HANDPIECE BECAME OVERHEATED. THE SURGEON LAID THE HOT HANDPIECE ON TOP OF THE STERILE DRAPES, WHICH WAS ON THE PATIENT WHILE THE ALTERNATIVE DRILL WAS OBTAINED AND USED. AT THE END OF THE PROCEDURE, THE PATIENT NOTICED 2 BLISTERS ON HER LEFT HAND THAT WAS DESCRIBED AS ¿PAINFUL¿. THE BLISTERS WERE REDUCED AND DRESSING APPLIED. SUBSEQUENTLY, THE (B)(6), FEMALE PATIENT HAS HAD TO BE REFERRED TO A PLASTIC CONSULTANT FOR FURTHER TREATMENT. FOLLOW-UP WITH THE USER FACILITY ON (B)(6) 2013 CONFIRMED THAT THE PATIENT WAS SEEN IN THE PLASTIC TRAUMA CLINIC AND WAS TREATED ¿CONSERVATIVELY¿. IT WAS ALSO REPORTED THAT THERE WAS ¿CRUSTING TO THE BURN AREAS AND WOULD PROBABLY BE SOME SCARING¿ TO THE PATIENT¿S LEFT HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237175 E9000 HIGH SPEED DRILL ARTHROSCOPE HRX CONMED LINVATEC

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention