BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO¿

    MDR report key: 4130341 · Received September 30, 2014

    Report

    Report Number
    1045254-2014-00236
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND REPAIR (DETAILED AS FOLLOWS): ANALYSIS WAS ABLE TO CONFIRM THE ALLEGED ISSUE, AS THE HEATRISE WAS 47 DEGREES F¿HOWEVER IT DID NOT RUN HOT DURING THE FIRST MINUTE OF TESTING BUT WITHIN 5 MINUTES. THE TEMPERATURE TESTS PRIOR TO REPAIR REVEALED THE FOLLOWING RESULTS IN THE TIMEFRAME OF ONE (1) MINUTE: T1: 96 DEGREES F ¿ T2: 79 DEGREES F; THEREFORE THE HOUSING WAS REPLACED AS A RESULT, ALONG WITH THE WORN MOTOR. METHOD: TEST FOR HIGH TEMPERATURE CONDITIONS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 AN INDIGO HIGH SPEED OTOLOGIC DRILL ¿HEATED UP¿ INTRAOPERATIVELY IN A 3-HOUR OTOLOGY PROCEDURE ON A (B)(4) MALE, WEIGHING 150 POUNDS. THE HEAT UP OCCURRED IN UNDER A MINUTE, DESCRIBED AS ¿TRANSFERRING VERY FAST¿. THERE WAS NO REPORTED PATIENT/USER IMPACT OR INJURY AS A RESULT OF THIS EVENT. ANOTHER DRILL WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606999 INDIGO¿ DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR