BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM

    MDR report key: 6126373 · Received November 23, 2016

    Report

    Report Number
    2916714-2016-00979
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 1, 2016
    Report Date
    June 26, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    HEW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF(B)(4) (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: UNITED KINGDOM. IT WAS REPORTED THAT THE DRILL HAND PIECE WAS OVER HEATED AND BURNT THE CORNER OF THE PATIENT'S MOUTH. THE SERIAL NUMBER OF THE HAND PIECE IS (B)(6) AND THE MODEL NUMBER IS GD450M. COMPONENT IN USE LISTED AS CONCOMITANT DEVICE ARE: GD450M / MICRO-LINE STRAIGHT HDR 1:1 F/2.35X70MM. JF212R / 1/1 SIZE PERF BSKET 485X253X56MM. GD678 / MICROSPEED UNI MICRO 150 MOTOR. GD672 / MICROSPEED UNI MOTOR CALE F/FOOT CTRL.

    Additional Manufacturer Narrative · 1

    DURING A FUNCTIONAL TEST RUNNING NOISES AND A RAPID INCREASE OF THE TEMPERATURE CAN BE RECOGNIZED. DUE TO A BROKEN BALL BEARING, IT WAS NOT POSSIBLE TO MOUNT A TOOL. THE INSIDE OF THE HOUSING IS SOILED, RESIDUES AND CORROSION CAN BE FOUND, THUS THE BEARING WAS DAMAGED. IT CAN BE ASSUMED THAT THE HAND PIECE WAS USED FOR A LONG TIME WITH THIS BROKEN BEARING, THUS THE TEMPERATURE INCREASED AND THE TIP WORN OUT. THE PROVIDED NOZZLE IS FLAWLESS, ONLY THE SURFACE IS SCRATCHED. A REVIEW OF THE DEVICE QUALITY AND MANUFACTURING HISTORY WAS NOT POSSIBLE BECAUSE THE DEVICE IS A PURCHASED PART. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF THE INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT MAINTENANCE OF THE DEVICE. A CAPA IS NOT NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776748 MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM HIGH SPEED POWER SYSTEMS HEW AESCULAP AG GD450M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other GD450M / MICRO-LINE STRAIGHT HDR 1:1 F/2.5X70MM| GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL| GD678 / MICROSPEED UNI MICRO 150 MOTOR| JF212R / 1/1 SIZE PERF BASKET 485X253X56MM| GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL| GD678 / MICROSPEED UNI MICRO 150 MOTOR| JF212R / 1/1 SIZE PERF BASKET 485X253X56MM