BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW SILVER RECIPROCATING MOTOR

    MDR report key: 12164422 · Received July 13, 2021

    Report

    Report Number
    9611053-2021-00228
    Event Type
    Malfunction
    Date Received
    July 13, 2021
    Report Date
    November 9, 2021
    Manufacturer
    DENTSPLY VDW GMBH
    Product Code
    EBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BATTERY (VOLTAGE BREAKS DOWN UNDER LOAD) DEFECTIVE. MOTOR CABLE (CABLE BREAK) DEFECTIVE. FOOT CONTROL 156487 MICROMOTOR SMR 1242393 AND CONTRA-ANGLE HANDPIECE 20590 (2010) CHECKED, WITHOUT ERRORS. THE HOUSING IS CRACKED (PRESUMABLY DUE TO AN IMPACT) AND HAS NO EFFECT ON THE FUNCTION.

    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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    "IN THIS EVENT IT WAS REPORTED THAT A VDW.SILVER RECIPROC STOPS DURING TREATMENT. THE DEVICE ALSO SHOW ERROR CODE AFTER CALIBRATION. DENTIST DOES NOT KNOW WHAT KIND OF ERROR CODE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061293 VDW SILVER RECIPROCATING MOTOR CONTROLLER, FOOT, HANDPIECE AND CORD EBW DENTSPLY VDW GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown