BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW.SILVER RECIPROC

    MDR report key: 24036218 · Received January 12, 2026

    Report

    Report Number
    9611053-2026-00008
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Report Date
    April 21, 2026
    Manufacturer
    VDW GMBH
    Product Code
    EBW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. 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 21 CFR 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.

    Additional Manufacturer Narrative · 0

    SIROFORCE NO. 8001368662: PROVIDED ACCESSORIES: CHARGING UNIT (30120-0174560), CONTRA ANGLE (55291), MICRO MOTOR WITH CABLE (SMR2386867), FOOT CONTROL (220567). DIAGNOSIS: BATTERY DEFECT (H:4:30:19, S:489, F:262: DEVICE WAS CHARGED 489X. ENOUGH WOULD HAVE BEEN 3X: BATTERY OVERCHARGED, MISUSE). NEEDED SERVICE FOR REPAIR: VR01103000900 BATTERY RECYCKO 1.000. SF2 SERVICE FEE 2 1.000 . ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A VDW.SILVER RECIPROC STOPPED OFTEN DURING TREATMENT. NO INJURY OCCURRED. WE DO NOT KNOW EXACTLY HOW MANY PATIENTS ARE AFFECTED, THEREFORE WE HAVE CREATED ANOTHER CASE FOR THIS EVENT. CASE 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299634 VDW.SILVER RECIPROC CONTROLLER, FOOT, HANDPIECE AND CORD EBW VDW GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1