BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BUR 1885061HS 3PK ROUND DIAMOND 5MM 15DE

    MDR report key: 1891677 · Received November 5, 2010

    Report

    Report Number
    1045254-2010-00056
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 2010
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH 3500A FORM WAS RECEIVED FROM THE REPORTER. ANY MISSING OR INCOMPLETE DATA ON THIS FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER. MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION WERE MADE, AND THE RECORDS OF THESE ATTEMPTS ARE DOCUMENTED IN THE COMPLAINT FILE. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS CLASSIFIED AS MEDICAL INTERVENTION SINCE AN ANTIBIOTIC OINTMENT WAS APPLIED PROPHYLACTICALLY. ALTHOUGH NO PERMANENT DAMAGE TO A BODY STRUCTURE HAS BEEN INDICATED, IT CANNOT BE RULED OUT. A DERMAL BURN MAY RESULT IN CELL DAMAGE OR SCARRING BUT, AS THE PHYSICIAN STATED, HE FEELS THAT THE INJURY WOULD NOT CAUSE ANY PERMANENT IMPAIRMENT TO THE PATIENT.

    Description of Event or Problem · 1

    DURING A LEFT ENDOSCOPIC TOTAL ETHMOIDECTOMY WITH A RIGHT AND LEFT ENDOSCOPIC SPHENOIDECTOMY PROCEDURE, THE BLADE GENERATED HEAT AND CAUSED A 1CM BY 1CM DERMAL BURN ON THE PATIENTS LIP. THE FACILITY STATED THAT THE PATIENT IS EXPECTED TO HEAL WITHOUT COMPLICATION. NO ADDITIONAL FOLLOW UP CARE WAS REQUIRED AS A RESULT OF THIS EVENT WITH THE EXCEPTION OF ANTIBIOTIC OINTMENT APPLIED TO THE BURN INJURY SITE. THE SURGERY PROCEEDED AS INTENDED WITHOUT ANY SIGNIFICANT DELAY. THE PHYSICIAN STATED THE HE FEELS THAT THE DEVICE WOULD NOT CAUSE ANY PERMANENT IMPAIRMENT TO THE PATIENT. AN EVALUATION ON ONE UNSTERILIZED RETURN SAMPLE WAS COMPLETED. THE SAMPLE WAS RECEIVED WITHOUT A PORTION OF THE BUR. THE PORTION MISSING WAS THE INNER HUB ALONG WITH 3/4 OF AN INCH OF THE PROXIMAL END OF THE INNER TUBE. THIS MISSING PORTION IS NOT LIKELY TO RESULT IN AN UNRETRIEVED DEVICE FRAGMENT, SINCE IT IS CONTAINED BY THE OUTER HUB AND / OR HANDPIECE. VISUAL INSPECTION SHOWED INDENTATIONS IN THE OUTER HUB LOCKING AREA INDICATING THAT THE BUR WAS LOADED PROPERLY, BUT THERE IS EVIDENCE THAT SIDE LOADING OR EXCESSIVE PRESSURE OCCURRED DURING USE. THE DIAMOND TIP WAS COMPACTED WITH BIOLOGICAL CONTAMINANTS, AND BIOLOGICAL CONTAMINATION WAS FOUND ALL THE WAY UP TO AND BEYOND THE CLEAR BAND. THE CLEAR BAND AROUND THE IRRIGATION TUBE AND OUTER TUBE SHOWED SIGNS OF THERMAL DAMAGE (MELTING) AROUND 2 INCHES FROM THE PROXIMAL END OF THE OUTER HUB. THIS BAND ALSO APPEARED TO HAVE SHIFTED FORWARD TOWARD THE DISTAL END OF THE TIP BY 1/8 OF AN INCH. THE EXTERIOR OF THE OUTER HUB WAS DEFORMED ON ONE SIDE 3/4 OF AN INCH FROM THE PROXIMAL END OF THE HUB. THIS DEFORMATION CORRESPONDS TO THE BREAK POINT OF THE INNER TUBE, AS WELL AS THE END OF THE METAL PORTION OF THE OUTER TUBE. EVIDENCE INDICATES THAT THIS AREA WAS THE SOURCE OF THE HEAT. INSPECTION OF THE INSIDE OF THE OUTER HUB IN THIS LOCATION ALSO APPEARED TO SHOW SIGNS OF MELTING. NO OBSTRUCTIONS WERE FOUND IN THE IRRIGATION OR SUCTION PORTS. EVIDENCE OF LUBRICATING GREASE WAS FOUND AT THE PROXIMAL END OF THE OUTER HUB ON THE METAL BUSHING, PER MANUFACTURING SPECIFICATIONS. THE FACILITY STATED THAT THE DEVICE SPEED DID NOT GO OVER THE RECOMMENDED 12,000 RPM IN FORWARD MOTION AND THAT THE IRRIGATION WAS WORKING AND WAS BEING USED. INSTRUCTIONS FOR USE STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO - USE ADEQUATE IRRIGATION FROM A SEPARATE USER-PROVIDED IRRIGATING SOURCE. THE USE OF AN ACCESSORY WITHOUT IRRIGATION MAY CAUSE AN INORDINATE AMOUNT OF HEAT BUILDUP RESULTING IN THERMAL INJURY TO TISSUE. DURING THE PROCEDURE, IT IS RECOMMENDED TO PERIODICALLY SUBMERSE THE BLADE IN STERILE WATER WITH SUCTION CONNECTED TO THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUR 1885061HS 3PK ROUND DIAMOND 5MM 15DE BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED INC. 1885061HS 64497200

    Patients

    Seq Age Sex Outcome Treatment
    1 00013 YR Required Intervention