BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRILL 3334800 VISAO 80K HANDPIECE

    MDR report key: 3204484 · Received July 3, 2013

    Report

    Report Number
    1045254-2013-00441
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K011321
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THIS DEVICE IS 69056800.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCTS: 3318606, COOLING SET 3318606 2PK IPC VISAO; 0206652661 ERL, 510K: K081277 MANUFACTURED 1-31-2013, USE BEFORE 1-30-2017; 31316058U BUR 31316058U ULTRA 5PK 6MM MED LENGTH; 0205715653 EQJ 510K: EXEMPT MANUFACTURED 2-9-2012, USE BEFORE 2-8-2016; 31314068U BUR 31314068U ULTRA 5PK 4MM LONG LENGTH; 68111900 EQJ 510K: EXEMPT MANUFACTURED 6-16-2010, USE BEFORE 6-8-2014. (B)(4). EVALUATION SUMMARY NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. METHOD: NO TESTING METHODS PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE RECEIVED JULY 10, 2013, FOR EVALUATION. EVALUATION SUMMARY: DEVICE ANALYSIS FOUND THAT THE NOSE BEARINGS ARE NOISY AND SOUND DRY; WITH A SHORT BUR ATTACHED, THERE IS NO VIBRATION NOTICEABLE. WITH A LONG BUR, USED WITHOUT BUR-GUARD, THERE IS SOME VIBRATION AS TO BE EXPECTED. IF THE BUR GUARD WAS USED, BUT HAS A BROKEN BEARING OF ITS OWN, THIS COMPLAINT WILL OCCUR. THE DEVICE HAS BEEN COMPLETELY DISASSEMBLED AND CLEANED. ALL BEARINGS AND O-RINGS HAVE BEEN REPLACED PRECAUTIONARY. ONLY ONE OF THE NOSE BEARINGS WAS WORN. THE VISAO HAS BEEN SUCCESSFULLY TESTED ACCORDING TO MANUFACTURING SPECIFICATIONS. PER OUR VISAO INSTRUCTIONS FOR USE (MANUAL DOCUMENT NUMBER: (B)(4)): VISAO BUR GUARD ASSEMBLY IMPORTANT: ON THE VISAO, A BUR GUARD IS REQUIRED FOR USE WITH ALL BURS. SLIDE BUR GUARD OVER THE FRONT END OF THE VISAO UNTIL FULLY SEATED. PER OUR BUR INSTRUCTIONS FOR USE (MANUAL DOCUMENT NUMBER: (B)(4)): ENSURE BUR IS PROPERLY SECURED IN THE HANDPIECE PRIOR TO SURGEON ACTIVATION. TEST FOR BUR WOBBLE (ECCENTRICITY) AT THE DESIRED SPEED PRIOR TO USE. USE A BUR GUARD, IF NEEDED. SELECT A NEW BUR IF WOBBLE IS OBSERVED OR REDUCE SPEED. - ECCENTRICITY OF THE BUR CAN CAUSE BUR VIBRATION AND MAY RESULT IN EXCESS TISSUE AND BONE DESTRUCTION AND HEARING DAMAGE. - DURING PROCEDURES, OPERATING ROOM TECHNICIANS AND NURSES SHOULD ALWAYS CHECK FOR BUR FUNCTION, FIT, TIGHTNESS, AND SECURITY IN THE HANDPIECE BEFORE HANDING OFF TO THE SURGEON FOR USE. TUG ON BUR TO ENSURE BUR IS SECURED AND LOCKED INTO THE HANDPIECE. IMPORTANT: TEST DRILL BY DEPRESSING FOOT PEDAL PRIOR TO USE. IMPORTANT: ALWAYS EXAMINE OPERATION OF EACH BUR IN A HANDPIECE BEFORE EACH USE. OPERATING CERTAIN BURS AT HIGH SPEEDS CAN CAUSE VIBRATION OF THE BUR. THE FOLLOWING ARE SUGGESTIONS FOR REDUCING BUR VIBRATION: REDUCE HANDPIECE OPERATING SPEED. USE ONLY BURS THAT ARE RATED FOR CONSOLE SPEED SELECTED. USE VISAO HI-SPEED GUARDS WITH MEDIUM AND LONG BURS. OPERATE HANDPIECE AT 50% SPEED WHEN USING BURS 75 MM OR LONGER. SELECT A NEW BUR.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS USING THE DRILL TO PERFORM A COMPLEX MASTOID USING NERVE MONITORING (NIM) DUE TO CONGENITAL ABNORMALITIES IN THE PATIENT. HE REPORTED THAT THE BUR "JUMPED" AND IN THE PROCESS TOOK A PIECE OF THE TYMPANIC MUSCLE WITH IT. HE HAD TO REPAIR/SUTURE THE DAMAGE DONE. HE WAS NOT ABLE TO USE THE DRILL FURTHER AND HAD TO MAKE USE OF A REPLACEMENT DRILL. IT HAS BEEN CONFIRMED THAT THE PATIENT HAS HAD NO POST-OPERATIVE COMPLICATIONS. IT WAS ALSO NOTED THAT THE PHYSICIAN REPORTED THAT THE DEVICE HAD BEEN MAKING A NOISE BEFORE USING IT, AND THAT THEY HAD BATTLED TO 'SEAT' THE BUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303976 DRILL 3334800 VISAO 80K HANDPIECE DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL MEDTRONIC XOMED, INC. 3334800 69056800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention