BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW SILVER RECIPROCATING MOTOR

    MDR report key: 10431847 · Received August 20, 2020

    Report

    Report Number
    9611053-2020-00125
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Report Date
    August 20, 2020
    Manufacturer
    VDW GMBH
    Product Code
    EBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE STALLING HAS CAUSED FILE SEPARATION. 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, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. MOTOR CONNECTION CABLE (LOOSE CONTACT) DEFECTIVE, BATTERY (VOLTAGE BREAKS DOWN UNDER LOAD) DEFECTIVE. MICROMOTOR SM15291 (DETECTED OIL IN MOTOR) DEFECTIVE, CONTRA ANGLE 99927 (2016) AND FOOT CONTROL 182612 DO NOT INDICATE A DEFECT. (ST: 47; FI: 40; WORKING HOURS: 58:22:30; ENOUGH IS: 30). PLEASE NOTE THAT WHILE THIS PRODUCT IS NOT SOLD IN THE US, IT IS CONSIDERED SIMILAR TO PRODUCTS THAT ARE MARKETED IN THE US BY DENTSPLY SIRONA. NOTE: THE COVID-19 PANDEMIC CAUSED A DISRUPTION IN NORMAL BUSINESS ACTIVITIES, RESULTING IN LATE SUBMISSION OF THIS REPORT.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A SILVER RECIPROC MOTOR STOPS DURING USE; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895829 VDW SILVER RECIPROCATING MOTOR CONTROLLER, FOOT, HANDPIECE AND CORD EBW VDW GMBH NA

    Patients

    Seq Age Sex Outcome Treatment
    1