BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSPEED UNI MICRO 150 MOTOR

    MDR report key: 5554662 · Received April 7, 2016

    Report

    Report Number
    2916714-2016-00256
    Event Type
    Malfunction
    Date Received
    April 7, 2016
    Date of Event
    February 26, 2016
    Report Date
    November 1, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    HBC
    PMA / PMN Number
    K053526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). DURING FACIAL FEMINIZATION PROCEDURE, THE DENTAL DRILL STOPPED WORKING AND SHOWED AN ERROR CODE 6. SURGICAL DELAY OF APPROXIMATELY 15 MINUTES. COMPONENTS INVOLVED: GD678 / MICROSPEED UNI MICRO 150 MOTOR / LOT NUMBER 52179539; GD672 / MICROSPEED UNI MOTOR CABLE F/FOOT CTRL. / LOT NUMBER 52173174; GD450M / MICRO-LINE STRAIGHT HDPC 1:1 F/2.35X70MM / SERIAL NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    THE RECEIVED PRODUCTS WERE SUBJECTED TO FUNCTIONAL TESTING; IT WAS DETERMINED THAT THERE WERE NO DEVIATION PRESENT. THE RUNNING NOISE AND TEMPERATURE ARE ACCORDING TO SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED. THE PRODUCT WAS CHECKED ON ITS FUNCTION. IN TERMS OF MATERIAL AND MANUFACTURING WE FOUND THE PRODUCT ACCORDING TO OUR SPECIFICATIONS. IN OUR ANALYSIS WE DID NOT FIND A DEFECT, NOR WERE WE ABLE TO SIMULATE THE MALFUNCTION DURING TESTING. THE PRODUCT IS WITHOUT FAILURE. CORRECTIVE/PREVENTIVE ACTION IS NOT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215142 MICROSPEED UNI MICRO 150 MOTOR DRILL MOTOR HBC AESCULAP AG GD678 52179539

    Patients

    Seq Age Sex Outcome Treatment
    1 Other