BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO¿

    MDR report key: 4247739 · Received November 13, 2014

    Report

    Report Number
    1045254-2014-00292
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE RETURNED AND EVALUATED BY THE QUALITY ENGINEERING TEAM. AS RECEIVED CONDITION: RECEIVED INDIGO MOTOR AND STRAIGHT AND ANGLED ATTACHMENTS FOR EVALUATION BY THE ENGINEERING GROUP. THE CONDITION OF THE DEVICES SHOWED NO SIGNIFICANT PHYSICAL DAMAGES. EQUIPMENT USED: TEST IPC CONSOLE (PROVIDED BY S<(>&<)>R). OBSERVATIONS: THE INDIGO MOTOR WAS CONNECTED TO THE IPC AND RUN AT DEFAULT SPEED WITH THE STRAIGHT AND ANGLED ATTACHMENTS. THE HANDPIECE FUNCTIONED AND SOUNDED NORMAL. THE MOTOR PASSED THE TEMPERATURE TEST AT 1 MIN NOT EXCEEDING 118.4°F. THE ATTACHMENTS TEMPERATURES MEASURED 85°F AND 90°F; NO FAULT WAS FOUND WITH EITHER OF THE ATTACHMENTS. THE UNDERLYING CAUSE CANNOT BE DETERMINED BASED SOLELY ON THE EVALUATION RESULTS. METHODS ¿ ACTUAL DEVICE EVALUATED; MECHANICAL EVALUATION; THERMAL ENERGY EVALUATION; VISUAL INSPECTION. RESULTS ¿ WEAR PROBLEM. CONCLUSION ¿ DEVICE REPAIRED AND RETURNED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT. (B)(4) (ATTACHMENT, INDIGO OTOLOGY STRAIGHT); MANUFACTURE DATE ¿ FEBRUARY 27, 2012; SERIAL NUMBER - (B)(4); LOT ¿ 205834321; 510K - K081475 1845020 (ATTACHMENT, INDIGO OTOLOGY ANGLED); MANUFACTURE DATE ¿ FEBRUARY 27, 2012; SERIAL NUMBER - (B)(4); LOT - 205826895; 510K - K081475. (B)(4). THE DEVICES HAVE BEEN RECEIVED. HOWEVER, THE PRODUCT ANALYSIS HAS NOT YET BEEN COMPLETED. METHOD: NO TESTING METHODS PERFORMED. (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 THE DRILL AND ATTACHMENTS OVERHEATED. LUBRICATION WAS PERFORMED/APPLIED AS INDICATED IN THE USER'S MANUAL. THERE WAS NO REPORTED INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734092 INDIGO¿ DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 206044318

    Patients

    Seq Age Sex Outcome Treatment
    1