BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FSI-SLI-FG-10S INS,PKD

    MDR report key: 21137977 · Received January 13, 2025

    Report

    Report Number
    2424472-2025-00200
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Report Date
    March 28, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D003820051
    PMA / PMN Number
    K052334/K970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE AN OVERHEATING INSERT 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 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, 23300, 30K FSI-SLI-10S-KJ, (B)(6) BUL PER MANUFACTURE DATE: 30K TEST METHOD / GP005-WI02. INDUCTANCE: GAUGE ID# (B)(4) DUE: (B)(6) 2026 RESULT 3.14. 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)(6) DUE DATE: (B)(6) 2025 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 IS GOOD, NO FAULT FOUND. INSERT WAS TESTED ON A DIGITAL THERMOMETER I.D (B)(4). DUE DATE: (B)(6) 2025. THE TEMPERATURE WAS 88.7 °F, NO FAULT FOUND. THE SPECIFICATIONS STATE THE TEMPERATURE IS NOT TO EXCEED 118.4°F. (PER (B)(4). ALLEGED EVENT: CONFIRMED - NOT CONFIRMED.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS,PKD ALLEGEDLY THE INSERT HEATS UP TOO MUCH. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462089 30K FSI-SLI-FG-10S INS,PKD SCALER, ULTRASONIC ELC DENTSPLY LLC UNK D003820051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown