BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLFLEX E9000 HIGH SPEED DRILL

    MDR report key: 1242217 · Received November 19, 2008

    Report

    Report Number
    1017294-2008-00353
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 27, 2008
    Manufacturer
    CONMED LINVATEC
    Product Code
    HTW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COULD NOT DETERMINE WHICH HANDPIECE OR BUR GUARD WAS IN USE AT THE TIME OF THE EVENT; THEREFORE, CONMED LINVATEC RECEIVED MULTIPLE DEVICES TO EVALUATE. INVESTIGATION RESULTS: CONMED LINVATEC RECEIVED TWO E9010 DRILLS FOR EVALUATION. DURING TESTING OF EACH DRILL, OVERHEATING WAS NOT VERIFIED. BOTH HANDPIECES MET THE MANUFACTURER TEMPERATURE SPECIFICATIONS. EACH DEVICE WAS TESTED FOR OVERHEATING AT THE NOSE, COLLET AND MOTOR SECTION OF THE DEVICE. IN ADDITION, PERFORMANCE TESTING ON BOTH DEVICES FOUND THAT EACH FUNCTIONED TO SPECIFICATION. THE MANUFACTURE DATES OF BOTH DEVICES ARE 04/2006 AND 05/2006 RESPECTIVELY. NEITHER DRILL HAS A REPAIR HISTORY, AND ACCORDING TO THE USER, THIS IS FIRST TIME USE FOR THEIR DRILLS. CONMED LINVATEC ALSO RECEIVED SEVERAL BUR GUARDS FOR EVALUATION. DURING TESTING, EACH BUR GUARD (E9011-1, LOT#: MAY06; E9011-2, LOT#: FEB06; & E9011-3, LOT#: JUL07) MET MANUFACTURER TEMPERATURE SPECIFICATION. IN ADDITION, PERFORMANCE TESTING ON EACH BUR GUARD FOUND THAT EACH FUNCTIONED TO SPECIFICATION. THIS DRILL IS USED IN CONJUNCTION WITH IRRIGATION SUPPLIED BY A TUBING SET TO PROVIDE COOLING FOR THE HANDPIECE BODY. THE CUSTOMER REPORTED THAT THIS IRRIGATION WAS IN USE DURING THIS EVENT. THE USER MANUAL CAUTIONS: COOLING FOR THE HANDPIECE BODY IS RECOMMENDED AT ALL TIMES. THE TUBING SET MUST BE FULLY PRIMED OR THE HANDPIECE WILL OVERHEAT AND CAUSE DAMAGE TO THE DRILL. THE USER IS WARNED THAT USE OF A DRILL NOT FUNCTIONING PROPERLY CAN RESULT IN PATIENT OR USER INJURY. A PERFORMANCE TEST PRIOR TO USE IS PROVIDED IN THE MANUAL FOR THIS DRILL AND BUR GUARDS. IN ADDITION, THE SERVICE INTERVAL FOR THIS DRILL AND BUR GUARDS IS DOCUMENTED FOR EVERY 6 MONTHS. ALTHOUGH NO EVIDENCE COULD BE FOUND THAT ANY DEVICE OVERHEATED, ADDITIONAL INFORMATION WILL BE PROVIDED TO THE CUSTOMER ON USE OF THESE PRODUCTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING USE OF THIS DRILL TO PERFORM AN ANTERIOR CERVICAL FUSION PROCEDURE, IT GOT HOT. THE SURGEON FELT THE HEAT IN THE BODY OF THE HANDPIECE; DISCONTINUED USE OF THE DRILL, AND A BACK-UP DEVICE WAS OBTAINED TO COMPLETE THE SURGERY. AT THIS TIME, THE SURGEON NOTED SOME REDNESS TO THE PATIENT'S SKIN. IN A FOLLOW-UP VISIT ONE WEEK LATER, WHEN THE SURGICAL DRESSING WAS REMOVED, TWO AREAS OF THE SURGICAL SITE WERE FOUND WITH A THIRD DEGREE BURN. AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE REGARDING THE PATIENT'S STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOLFLEX E9000 HIGH SPEED DRILL DRILL, SURGICAL, ENT HTW CONMED LINVATEC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NK Other E9011-3| E9011-1| E9011-2