BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FSI-SLI-FG-1000 INS,PKD

    MDR report key: 20987351 · Received December 20, 2024

    Report

    Report Number
    2424472-2024-00409
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Report Date
    March 7, 2025
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    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

    INSERT RECEIVED HAS A DIFFERENT LOT NUMBER THAN THE LOT # IN THE COMPLAINT. RETURN QTY. 1, 24004, 30K FSI-SLI-1000 FG-39, 00112546 BUL. 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)(4) 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: MEETS SPEC 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:09/30/2025. THE TEMPERATURE WAS 86.5 °F, NO FAULT FOUND. THE SPECIFICATIONS STATE THE TEMPERATURE IS NOT TO EXCEED 118.4°F. (PER FRS-9175). ALLEGED EVENT: CONFIRMED - NOT CONFIRMED.

    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.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-1000 INS, PKD ALLEGEDLY THE INSERT WAS HEATING UP. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2151899 30K FSI-SLI-FG-1000 INS,PKD SCALER, ULTRASONIC ELC DENTSPLY LLC 00112548

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown