BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTACHMENT INDIGO DRILL ANGLED

    MDR report key: 3114220 · Received May 15, 2013

    Report

    Report Number
    1045254-2013-00384
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 23, 2013
    Report Date
    August 14, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). CONCOMITANT DEVICE: DRILL 1845000 INDIGO HIGH SPEED OTOLOGIC (ID: 1845000, SN: (B)(4), LOT: 206496449, MANUFACTURED JANUARY 2, 2013).

    Additional Manufacturer Narrative · 1

    HBE - DRILLS, BURRS, TREPHINES <(>&<)> ACCESSORIES (SIMPLE, POWERED). A TOTAL OF 2 DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION AND REPAIR. ANALYSIS WAS NOT ABLE TO DUPLICATE THE ALLEGED COMPLAINT OF HEAT WITH EITHER DEVICE (DETAILED AS FOLLOWS): 1845000 (QUANTITY 1) ¿ PRE-TEMPERATURE TEST ON HANDPIECE FOUND NO FAULT. RISE TEMPERATURE WAS 13.7F, WHICH IS WITHIN SPECIFICATION. ONLY WHILE RUNNING THE HANDPIECE WITH THE COLLET IN THE LOCKED POSITION, IT WOULD RUN HOT...HOWEVER THIS IS NOT THE CASE WHEN OPERATING, THE COLLET MUST BE IN THE UNLOCKED POSITION WHILE THE ATTACHMENT IS IN THE LOCKED POSITION. 1845020 (QUANTITY 1) ¿ THE ATTACHMENT WAS RAN FOR 5 MINUTES AND ONLY REACHED A MAXIMUM TEMPERATURE OF 108 DEGREES. THERE WAS NOTICEABLE WEAR ON THE BEARINGS AND CORROSION ON THE INPUT AND OUTPUT DRIVE SHAFTS. METHOD: TEST FOR HIGH TEMPERATURE CONDITIONS.

    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 DURING A PROCEDURE ON A (B)(6) FEMALE IN WHICH AN INDIGO DRILL AND ATTACHMENT WERE BEING USED, THE DRILL AND ATTACHMENT GOT HOT. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR DEVICE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215635 ATTACHMENT INDIGO DRILL ANGLED DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED, INC. 1845020

    Patients

    Seq Age Sex Outcome Treatment
    1 00007 YR