BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VDW.SILVER RECIPROC

    MDR report key: 17623100 · Received August 25, 2023

    Report

    Report Number
    9611053-2023-00833
    Event Type
    Malfunction
    Date Received
    August 25, 2023
    Report Date
    September 21, 2023
    Manufacturer
    VDW GMBH
    Product Code
    EBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THERE WAS NO INJURY THAT OCCURRED IN THIS EVENT. INVESTIGATION RESULTS: FAILURE MODE: SPEED INCORRECT/TOO FAST/TOO SLOW ROOT CAUSE: BATTERY LEVEL TOO LOW TO BE RECHARGED (TOO LONG STORAGE IN WAREHOUSE) CONCLUSION CODE: POTENTIAL USER HANDLING/STORAGE ISSUE (B)(6) :BATTERY (VOLTAGE COLLAPSES UNDER LOAD) DEFECTIVE, REPLACED. THE MICROMOTOR SMR1870627, CONTRA-ANGLE 28472 (2011) AND FOOT CONTROL 120471 TESTED, WITHOUT ERRORS. FUNCTIONAL TEST WITHOUT ERRORS. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    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 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE 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 THAT A VDW.SILVER RECIPROC STOPS DURING TREATMENT. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386828 VDW.SILVER RECIPROC CONTROLLER, FOOT, HANDPIECE AND CORD EBW VDW GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown