BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISAO HIGH SPEED OTOLOGIC DRILL (DEVICE 1 OF 4)

    MDR report key: 1210714 · Received October 23, 2008

    Report

    Report Number
    1045254-2008-00026
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 23, 2008
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    EQJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DRILLS AND TWO RE-USABLE BUR GUARDS (USED TO DIRECT IRRIGATION AND TO CONTROL WOBBLE IN LONGER LENGTH BURS) THAT WERE USED IN THE PROCEDURE, WERE ANALYZED FOR PROPER FUNCTION. EVAL FOUND THE TWO DRILLS FUNCTIONED NORMALLY USING AN IN-HOUSE XPS 3000 CONSOLE, NO DELAY IN DELIVERY OR IRRIGATION WAS NOTED. THE TWO BUR GUARDS HAD A SLIGHT DRIP, BUT OTHERWISE, IRRIGATED NORMALLY USING AN IN-HOUSE DRILL BUR. DR REPORTED THAT IT WAS A STRAIGHT FLUTED BUR, BUT DID NOT KNOW HOW OLD IT WAS, OR ITS PART NUMBER. DR DID NOT SAVE THE BUR. SALES REP ADDED THAT AT NO TIME DURING THE PROCEDURE WAS THE MEDTRONIC XOMED NERVE INTEGRITY MONITOR UTILIZED.

    Description of Event or Problem · 1

    MEDTRONIC SALES REP REPORTED THAT DURING A LEFT TYMPANO-MASTOIDECTOMY, PHYSICIAN COMPLAINED THAT IRRIGATION TO THE DRILL BUR DID NOT FLOW IMMEDIATELY, IT WAS DELAYED FOR ABOUT 6 SECONDS, AND SEEMED TO DRIP AND SPRAY. TO COMPENSATE FOR THE DELAY, HE CONTINUED THE CASE BY DEPRESSING THE FOOT PEDAL AND NOT ENGAGING BONE UNTIL IRRIGATION FLOWED. WHILE CLOSING, SURGEON SAID THERE WAS POSSIBLE TRAUMA TO THE FACIAL NERVE. HE CITED THE DRILL AND THE PT'S ANATOMY AS CULPRITS. SAID THE DRILL BUR JUMPED OR SKIPPED DURING THE BRIEF INTERVAL THAT IT WAS LACKING IRRIGATION, AND THE FACIAL NERVE WAS DAMAGED. PT WAS TRANSFERRED TO A DIFFERENT HOSP FOR A FACIAL NERVE GRAFT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISAO HIGH SPEED OTOLOGIC DRILL (DEVICE 1 OF 4) SURGICAL ENT DRILL EQJ MEDTRONIC XOMED INC. 3334800T 44785500

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention P/N 3334635| P/N 1897102| 00027| REPORT# 1045254-2008-00029| 00026| P/N 3334800T| P/N NOT KNOWN