BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WST 6:1 F. VDW.GOLD/SILVER

    MDR report key: 15713872 · Received November 2, 2022

    Report

    Report Number
    9611053-2022-00664
    Event Type
    Malfunction
    Date Received
    November 2, 2022
    Report Date
    December 1, 2022
    Manufacturer
    VDW GMBH
    Product Code
    EGS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NC073695/GR23554/CA-SN:(B)(6):BATTERY (VOLTAGE COLLAPSES UNDER LOAD) DEFECTIVE, REPLACED. HANDPIECE TRAY (BROKEN) DEFECTIVE, REPLACED.CONTRA ANGLE02934(2006) DOES NOT HOLD THE FILES (COLLET DIRTY, PLAIN BEARING DAMAGE, HAS AN INCREASED ELECTRICAL RESISTANCE VALUE) DEFECTIVE. REPAIRED. MICROMOTOR GMR1658823 HAS NO ERROR. FOOT CONTROL, MEASURING CABLE SET, CHARGER COULD NOT BE CHECKED BECAUSE THEY WERE NOT INCLUDED. THE CASE HAS BROKEN IN SEVERAL PLACES (PROBABLY DUE TO AN IMPACT) HAS NO EFFECT ON THE FUNCTION. PLEASE FULLY CHARGE YOUR DEVICE BEFORE USING IT FOR THE FIRST TIME! FUNCTION TEST AND TEST MEASUREMENTS WITHOUT ERRORS S:119. F:81. NUMBERS OF HOURS OF USE: 27:30:42. 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 WITH A SIMILAR DEVICE 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 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 WST 6:1 F. VDW.GOLD/SILVER CONTRA ANGLE DOES NOT HOLD FILES. OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2914070 WST 6:1 F. VDW.GOLD/SILVER HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS VDW GMBH 02934 (2006)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown