BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FSI-SLI-10S INSERT,PKD

    MDR report key: 17286551 · Received July 10, 2023

    Report

    Report Number
    2424472-2023-00394
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Report Date
    September 25, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D003803951
    PMA / PMN Number
    K052334/K970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED QTY. (B)(4) INSERT, 80395, 22173 / (B)(6), JW, BEYOND USEFUL LIFE, TEST METHOD / GP005-WI02, INDUCTANCE: GAUGE ID#: 5349, DUE: 11/30/2024, RESULT: 3.24, 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: G136 GAGE ID#: 9626-2, DUE DATE: 09/30/2023, SET PRESSURE: 35 PSI, WATER FLOW: OUTPUT RATE: 35 PSI, MEETS SPEC, DOES NOT MEET SPEC: N/A. SPRAY PATTERN: 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 HAS HP SEALING WATER LEAK. ALSO INSERT WAS TESTED ON A DIGITAL THERMOMETER I.D.#: 6116A, DUE DATE: 09/30/2023. THE TEMPERATURE WAS 84.5° F, NO FAULT FOUND. THE SPECIFICATION STATES ARE 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 RESULTS ARE NOT AVAILABLE 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 30K FSI-SLI-10S INSERT,PKD; INSERT GETS HOT WHILE IN USE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542525 30K FSI-SLI-10S INSERT,PKD SCALER, ULTRASONIC ELC DENTSPLY LLC 80395 D003803951

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown