BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL

    MDR report key: 5783966 · Received July 11, 2016

    Report

    Report Number
    1625507-2016-00030
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    June 15, 2016
    Report Date
    June 15, 2016
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    K081475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE 1845000 (INDIGO DRILL) <(>&<)> 1845020 (INDIGO ANGLED ATTACHMENT): THE PRODUCT ANALYSIS INDICATES THAT THE REPORTED OVERHEATING WAS CONFIRMED. THE ONE-MINUTE PRE-REPAIR TEMPERATURE TEST RESULTS WERE 129 DEGREES F AND 133 DEGREES F. THE DRILL FAILED TESTS. NO REPAIRS WERE PERFORMED. (B)(4). CONCLUSION: USE ERROR CAUSED OR CONTRIBUTED TO EVENT .

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: 1845000 ¿ DRILL, INDIGO HIGH SPEED OTOLOGIC; SERIAL NUMBER ¿ (B)(4); LOT NUMBER - 209989479; MANUFACTURE DATE ¿ AUGUST 13, 2015; 510K - K081475. INITIAL INSPECTION PERFORMED BY MEDTRONIC (B)(4) INDICATES THAT THE SERVICE TECHNICIAN WAS UNABLE TO LOCK THE ATTACHMENT WITH THE BUR AND THE BUR LOCK WAS NOT TURNING. THE ATTACHMENT IS TO BE FORWARDED TO THE U.S. FOR ANALYSIS. 1845000 (DRILL): INITIAL INSPECTION PERFORMED BY MEDTRONIC (B)(4) INDICATES THAT THE DRILL WAS WORKING WELL. THE REPORTED OVERHEATING COULD NOT BE CONFIRMED. THE ONE-MINUTE PRE-REPAIR TEMPERATURE TEST RESULTS WERE AS FOLLOWS: 88.2 DEGREES F AT T1 AND 85.5 DEGREES F AT T2.

    Description of Event or Problem · 1

    THE AVAILABLE INFORMATION INDICATES THAT PRIOR TO USE, THE DRILL AND ATTACHMENT OVERHEATED RAPIDLY. THERE WAS NO INJURY REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435424 IPC® HANDPIECE ATTACHMENT - INDIGO¿ DRILL DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE MDT POWERED SURGICAL SOLUTIONS 1845020 210944762

    Patients

    Seq Age Sex Outcome Treatment
    1