BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INDIGO¿

    MDR report key: 4212597 · Received October 30, 2014

    Report

    Report Number
    1045254-2014-00279
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 3, 2014
    Report Date
    November 11, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED. THEREFORE, AN ANALYSIS HAS NOT YET BEEN PERFORMED. METHOD CODE: NO TESTING METHODS PERFORMED. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION INDICATES THE PRODUCT EVENT OCCURRED WHILE TESTING AND THERE WAS NO PATIENT INVOLVED. DEVICE AVAILABLE FOR EVALUATION: NOVEMBER 5, 2014. THE PRODUCT ANALYSIS INDICATES THAT THERE WAS NO FAULT FOUND WITH THE DEVICE. THE CUSTOMER¿S COMPLAINT COULD NOT BE CONFIRMED. DURING PRE-REPAIR TEMPERATURE TESTING, THE DEVICE¿S TEMPERATURE RISE STAYED WELL WITHIN SPECIFICATIONS. AT ONE MINUTE OF RUNNING, THE TEMPERATURE WAS 81 DEGREES F. AFTER FIVE MINUTES OF RUNNING, THE MAXIMUM TEMPERATURE OF THE DEVICE WAS 91 DEGREES F. (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

    FOLLOW-UP INFORMATION INDICATES THE PRODUCT EVENT OCCURRED WHILE TESTING AND THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 1

    THE AVAILABLE INFORMATION INDICATES THAT DURING A PROCEDURE THE HANDPIECE OVERHEATED. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE. NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696855 INDIGO¿ DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MEDTRONIC XOMED INC. 1845000 207661269

    Patients

    Seq Age Sex Outcome Treatment
    1