BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    START-X TIP EMS INSERT 3

    MDR report key: 20734165 · Received November 20, 2024

    Report

    Report Number
    8031010-2024-00144
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Report Date
    November 26, 2024
    Manufacturer
    MAILLEFER INSTRUMENTS HOLDING SARL
    Product Code
    ELC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, 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 21CFR PART 803. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE LOT NUMBER WAS PROVIDED AND RETAINED-PRODUCT TESTING AND/OR DHR REVIEW ARE PLANNED. THE RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVOLVED PRODUCT THAT BROKE DURING USE WAS NOT RETURNED AND CANNOT BE ANALYZED. MOREOVER, NO UNUSED START-X TIP EMS INSERT 3 IS AVAILABLE FOR EVALUATION. NOTHING UNUSUAL TO REPORT WAS FOUND DURING DHR REVIEW (BATCH #1833636). WE CANNOT RULE ON THE COMPLIANCE OF THE POWER SETTINGS SELECTED BY THE CUSTOMER IN COMPARISON WITH THE ONES RECOMMENDED BY MAILLEFER WHICH ARE EXCLUSIVELY GIVEN FOR EMS GENERATORS. ROOT CAUSES ARE NOT IDENTIFIED. WE WILL TRACK THIS KIND OF EVENT AND MONITOR THE TREND. GENERALLY SPEAKING, SEVERAL FACTORS MAY CONTRIBUTE TO BREAKAGE ISSUE, SUCH AS USURY, PRESSURE OR INCORRECT TECHNIQUE. ALL OF THESE FACTORS MAY AFFECT THE LONGEVITY OF THE TIP. ROOT CAUSES ARE NOT IDENTIFIED.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT START-X TIP EMS INSERT 3 BROKE DURING USE. ALL BROKEN PARTS WERE RETRIEVED FROM PATIENT'S MOUTH. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2313440 START-X TIP EMS INSERT 3 SCALER, ULTRASONIC ELC MAILLEFER INSTRUMENTS HOLDING SARL 1833636

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown