BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW.SILVER RECIPROC

    MDR report key: 18977305 · Received March 26, 2024

    Report

    Report Number
    9611053-2024-00054
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Report Date
    June 4, 2024
    Manufacturer
    VDW GMBH
    Product Code
    EBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NC081438/SR62080:BATTERY IS OVERCHARGED, DEFECTIVE. CHARGING- CYCLES STARTED 215 X. IN RELATION TO THE DEVICE´S WORKING HOURS (52:47:23) WOULD BE NECESSARY ONLY 26 CHARGING-CYCLES. MOTORHOLDER (BROKEN - DAMAGED HOUSING) DEFECTIVE, MIKROMOTOR SMR2182911 (WE DETECTED THE PRESENCE OF LIQUID OR OIL IN YOUR MOTOR WHEN CHECKING YOUR DEVICE) DEFECTIVE, FOOT CONTROL 201536 AND CONTRA-ANGLE 153543 (2021) CHECKED, WITHOUT ERRORS (SOME CRACKS IN METAL OF C/A). ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Additional Manufacturer Narrative · 0

    EVEN IF 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 · 0

    IN THIS EVENT IT IS REPORTED VDW. SILVER RECIPROC STOPS DURING USE. REPORTEDLY, NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441211 VDW.SILVER RECIPROC CONTROLLER, FOOT, HANDPIECE AND CORD EBW VDW GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown