BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASEPTICO ENDO DTC

    MDR report key: 1203733 · Received October 9, 2008

    Report

    Report Number
    2320721-2008-00091
    Event Type
    Malfunction
    Date Received
    October 9, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 10, 2008
    Manufacturer
    DENTSPLY TULSA
    Product Code
    GEY
    PMA / PMN Number
    K882526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE EVAL OF THE UNIT IS NOT COMPLETE AS OF THIS MDR EVAL AND SINCE SEPARATION OF A FILE COULD NECESSITATE MEDICAL / SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE DEVICE MALFUNCTIONED, AND THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE / CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY. THE FILE SEPARATION WILL BE REPORTED VIA ASR, AS APPROPRIATE. THE DEVICE WAS RETURNED TO THE PHYSICAL MFR FOR EVAL, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVAL RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ASEPTICO ENDO DTC POSSIBLY CAUSED SEVERAL FILES TO SEPARATE; OUTCOME OF THE EVENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASEPTICO ENDO DTC GEY DENTSPLY TULSA AEU-25 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PROTAPER UNIVERSAL ROTARY FILE