BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WST 6:1 F. VDW.GOLD/SILVER

    MDR report key: 15677834 · Received October 26, 2022

    Report

    Report Number
    9611053-2022-00651
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Report Date
    December 15, 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

    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 HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION FOUND: CLEANLINESS ISSUES. CONTRA ANGLE DIRTY. CLEANED AND OILED. BATTERY DEFECTIVE (EXAMPLE: LOW BATTERY LIFE, INTERNAL RESISTANCE TOO HIGH). OVERLOAD. NO CONTACT OR BAD CONTACT IN THE CABLE (WEAR OR SHOCK) / SHEATH OF A DAMAGED CABLE (WEAR OR SHOCK). MOTOR CABLE DEFECT. POTENTIAL USER HANDLING/STORAGE ISSUE. NC073614/GR34065/CA-SN:(B)(6):CONTRA ANGLE 113063 (2017) CLEANED AND OILED. BATTERY (WAS CHARGED 1017 TIMES WITH AN OPERATING TIME OF 90.40.16 HOURS, WHEREBY 45 CHARGING CYCLES WOULD HAVE BEEN SUFFICIENT) DEFECTIVE, REPLACED. MOTOR CABLE (SCREWING OPEN/PINS BENT/BROKEN) DEFECTIVE, REPLACED. MICROMOTOR GMR 1345275, FOOT CONTROL 206771, MEASURING CABLE SET AND POWER SUPPLY CHECKED, WITHOUT ERRORS. FUNCTION TEST AND TEST MEASUREMENTS WITHOUT ERRORS. 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 WST 6:1 F. VDW.GOLD/SILVER WON'T HOLD FILES. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2453262 WST 6:1 F. VDW.GOLD/SILVER HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS VDW GMBH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown