BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVEONE ENDO MOTOR

    MDR report key: 11742939 · Received April 28, 2021

    Report

    Report Number
    8031010-2021-00069
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Report Date
    October 6, 2021
    Manufacturer
    DENTSPLY MAILLEFER
    Product Code
    EBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    WE´VE CHECKED THE MENTIONED DEVICE. THERE WAS NO FAILURE FOUND. WE´VE CONTACTED THE DENTIST AGAIN AND FOUND OUT, THAT HE HAD USED THE WRONG PROGRAM. WE´VE INFORMED HIM TO USE THE DEVICE ACCORDING TO THE DFU.

    Additional Manufacturer Narrative · 1

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION HAS CAUSED FILE SEPARATION. SINCE SEPARATION OF A FILE COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE DEVICE WAS EVALUATED AND FOUND TO BE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A WAVEONE MOTOR PROGRAM DOES NOT WORK ANYMORE. AS A CONSEQUENCE A FILE BROKE IN THE CANAL; NO INJURY RESULTED. IT WAS FOUND OUT THAT THE DENTIST DID NOT USE THE CORRECT PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632458 WAVEONE ENDO MOTOR CONTROLLER, FOOT, HANDPIECE AND CORD EBW DENTSPLY MAILLEFER NA 3348

    Patients

    Seq Age Sex Outcome Treatment
    1