BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW GOLD/SILVER CONTRA ANGLE

    MDR report key: 11396904 · Received March 1, 2021

    Report

    Report Number
    9611053-2021-00045
    Event Type
    Malfunction
    Date Received
    March 1, 2021
    Report Date
    February 26, 2021
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EGS
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, CALIBRATION RELATED ISSUES IN ENDO MOTORS HAVE LED TO FILE SEPARATION IN THE PAST. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. MICROMOTOR GMR1878113 (WHEN CHECKING MOTOR WE FOUND RESIDUES OF LIQUIDS OR OIL) DEFECTIVE, REPLACED WITH GMR2088551. THE BATTERY WAS REPLACED AS A PREVENTIVE MEASURE. THE HOUSING HAS CRACKED IN SEVERAL PLACES (PRESUMABLY DUE TO AN IMPACT) HAS NO EFFECT ON THE FUNCTION. CONTRA-ANGLE HANDPIECE 101193 (2017), 45396 (2012) AND FOOT CONTROL 173891 CHECKED, WITHOUT ERRORS. FUNCTION TEST AND TEST MEASUREMENTS WITHOUT ERRORS.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A VDW.CONTRA ANGLE 6:1 FROM VDW. GOLD RECIPROC DEVICE CAUSES ERROR CODE 2 ON DEVICE. CUSTOMER HAS 3 DIFFERENT CONTRA ANGLES AND THEY ALL CAUSES ERROR CODE 2. THIS IS FOR THE 2ND OF THREE. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293261 VDW GOLD/SILVER CONTRA ANGLE HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS DENTSPLY VDW GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1