BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FSI-SLI-10S INSERT,PKD

    MDR report key: 21889949 · Received April 23, 2025

    Report

    Report Number
    2424472-2025-00213
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Report Date
    July 11, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D003803951
    PMA / PMN Number
    K052334/K970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE THIS EVENT RESULTED IN MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, IT MUST BE PRESUMED THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, THIS EVENT MEETS THE DEFINITION OF A REPORTABLE EVENT 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

    RETURN QTY. 1, 23172, 30K FSI-SLI-1000-33, 00100842 BUL PER MANUFACTURE DATE. TEST METHOD / GP005-WI02. INDUCTANCE: GAUGE ID# (B)(4). DUE: 12/31/2026 RESULT 3.08, MEETS SPEC, DOES NOT MEET SPEC N/A. TIP CONDITION: MEETS SPEC, DOES NOT MEET SPEC N/A. STACK CONDITION, MEETS SPEC, DOES NOT MEET SPEC, N/A. TESTED ON: G130 GAGE ID# (B)(4) DUE DATE: 09/30/25 SET PRESSURE: 35 PSI. WATER FLOW: OUTPUT RATE: 35 PSI - MEETS SPEC, DOES NOT MEET SPEC, N/A. SPRAY: - MEETS SPEC, DOES NOT MEET SPEC, N/A. WATER LEAK: HP SEALING RING, PROXIMAL RING, DISTAL RING. SEAM LEAK, N/A. VIBRATION: - MEETS SPEC, DOES NOT MEET SPEC, N/A. GRIP CONDITION: MEET, DOES NOT MEET SPEC, N/A. OTHER VISUAL OBSERVATION: INSERT TIP IS BROKEN AT THE EDM HOLE. INSERT WAS TESTED ON A DIGITAL THERMOMETER I.D.#6116A. DUE DATE:09/30/2025. THE TEMPERATURE WAS 73.8 °F, NO FAULT FOUND. THE SPECIFICATIONS STATE THE TEMPERATURE IS NOT TO EXCEED 118.4°F. (PER FRS-9168 REV 6). ALLEGED EVENT: CONFIRMED, NOT CONFIRMED.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-10S INSERT, PKD TIP BROKE DURING USE. IT IS UNSURE WHEN THE TIP BROKE, DOCTOR WAS CONCERNED THE PATIENT MAY HAVE SWALLOWED IT AND WAS SENT TO CHECK IF PATIENT DID SWALLOW BROKEN PART. FOUND THAT PATIENT DID NOT SWALLOW TIP. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257874 30K FSI-SLI-10S INSERT,PKD SCALER, ULTRASONIC ELC DENTSPLY LLC UNK D003803951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown