BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FSI-PWR-FG-10 INSERT,PKD

    MDR report key: 20392420 · Received October 7, 2024

    Report

    Report Number
    2424472-2024-00398
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Report Date
    December 28, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D003820021
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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, 23270, 30K FS-PWR-10 FG-27, 00107007 BUL. 30K. TEST METHOD / GP005-WI02. INDUCTANCE: GAUGE ID#: 5349, DUE: 11/30/2024, 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#: 9626-2, DUE DATE: 03/31/2025, 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 TIP IS CLOGGED, NO WATER FLOW. ALLEGED EVENT: CONFIRMED, NOT CONFIRMED.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-FG-10 INSERT,PKD HAS NO WATER FLOW AND GETS HOT. NO INJURY REPORTED SINCE IT WAS NOT USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217168 30K FSI-PWR-FG-10 INSERT,PKD SCALER, ULTRASONIC ELC DENTSPLY LLC 23270/27 D003820021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown