BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPERTMATIC LUX E25 L

    MDR report key: 3061301 · Received April 10, 2013

    Report

    Report Number
    3003637274-2013-00009
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 20, 2013
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ANALYSIS IT WAS FOUND THAT BLACK GRITTY RESIDUE HAS BEEN INSIDE THE HANDPIECE. THIS IS THE ABRASION FROM THE MOVING PARTS, E.G. THE BEARINGS AND IS THE RESULT OF THE NORMAL WEAR PROCESS. THE RESIDUE AND THE WORN PARTS CAUSED THE HEAD TO HEAT UP. THE USER INSTRUCTION REQUEST A VISUAL AND FUNCTIONAL TEST PRIOR TO EACH TREATMENT TO ENSURE THAT THE HANDPIECE IS RUNNING WITHIN SPEC. REPORTED DUE TO THE 2 YEARS PRESUMPTION RULE.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT, THE HANDPIECE HEATED UP. IT WAS FIRST REPORTED THAT THE PT HAS BEEN BURNED, BUT WHEN WE TALKED TO THE DENTAL OFFICE IT WAS STATED THAT NOBODY WAS INJURED. DENTAL OFFICE DOES NOT RECALL NAME OF THE PT, HENCE NO MORE DATA ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153786 EXPERTMATIC LUX E25 L DENTAL HANDPIECE EFB KAVO DENTAL GMBH E25 L

    Patients

    Seq Age Sex Outcome Treatment
    1