BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROULTRA ENDO TIPS

    MDR report key: 1813378 · Received August 20, 2010

    Report

    Report Number
    2320721-2010-00123
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    DENTSPLY TULSA DENTAL SPECIALTIES
    Product Code
    ELC
    PMA / PMN Number
    K960889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH THERE WAS NO REPORT OF PATIENT INJURY, THERE HAVE BEEN PREVIOUS REPORTS OF THIS MALFUNCTION IN THE PAST TWO YEARS THAT NECESSITATED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR FUNCTION (THOUGH SUCH INTERVENTION IS INADVISABLE PER EXPERT OPINION PROVIDED BY DR. (B)(4)). THEREFORE, THIS EVENT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS RETURNED, VISUALLY INSPECTED, AND NO DEFECTS OR MARKINGS WERE NOTED ON THE INSTRUMENT. SEVERAL FACTORS MAY CONTRIBUTE TO BREAKAGE OF A TIP, SUCH AS INTENSITY AND PRESSURE, CORRECT TECHNIQUE, AND POWER SETTINGS. ALL OF THESE FACTORS MAY AFFECT THE LONGEVITY OF THE TIP. BASED UPON THE INFORMATION RECEIVED AND CONDITION OF THE INSTRUMENT RETURNED, DETERMINATION OF WHETHER THE EVENT WAS CAUSED BY USE FACTORS CANNOT BE MADE.

    Description of Event or Problem · 1

    IN THIS INCIDENT, A PROULTRA TIP #5 SEPARATED DURING USE. THE SEPARATED TIP WAS RETRIEVED AND THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROULTRA ENDO TIPS ELC DENTSPLY TULSA DENTAL SPECIALTIES 214007

    Patients

    Seq Age Sex Outcome Treatment
    1