BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO¿

    MDR report key: 4111233 · Received September 23, 2014

    Report

    Report Number
    1045254-2014-00231
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE ATTACHMENT WAS EVALUATED AND FOUND TO HAVE CORRODED BEARINGS.

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. METHOD ¿ NO TESTING METHODS PERFORMED FDA. RESULTS ¿ NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSION ¿ DEVICE NOT RETURNED. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY THE QUALITY ENGINEERING TEAM. AS RECEIVED CONDITION: RECEIVED INDIGO MOTOR AND ANGLED ATTACHMENT FOR EVALUATION BY THE ENGINEERING GROUP. THE CONDITION OF THE DEVICES SHOWED NO SIGNIFICANT PHYSICAL DAMAGES. ANALYSIS RESULTS: 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 ANGLED ATTACHMENT. THE HANDPIECE FUNCTIONED AND SOUNDED NORMAL. THE DEVICE PASSED TEMPERATURE TESTING WITH THE MEASURED TEMPERATURE AFTER 1 MINUTE OF RUN-IN AT 92.3F. BASED ON THE ABOVE OBSERVATIONS THE UNDERLYING CAUSE COULD BE DETERMINED AS THE REPORTED COMPLAINT ¿HEAT¿ COULD NOT BE CONFIRMED. THE DEVICE WAS REPAIRED AND TESTED TO PRODUCT SPECIFICATIONS AND RETURNED TO THE CUSTOMER. (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 ¿DURING THE SURGICAL PROCEDURE THE HANDPIECE HEATS.¿ NO EVENT DATE WAS PROVIDED. THERE WAS NO PATIENT IMPACT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590138 INDIGO¿ DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 206258008

    Patients

    Seq Age Sex Outcome Treatment
    1