BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FSI-SLI-1000 INSERT,PKD

    MDR report key: 21801475 · Received April 8, 2025

    Report

    Report Number
    2424472-2025-00212
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Report Date
    July 11, 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

    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, (B)(4), 30K FSI-SLI-1000-44, 00122920 BUL PER MANUFACTURE DATE. TEST METHOD / GP005-WI02 - INDUCTANCE: GAUGE ID# 5349, DUE: (B)(6) 2026, RESULT 3.11. 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: (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 TIP IS BENT. INSERT WAS TESTED ON A DIGITAL THERMOMETER I.D.# 6116A. DUE DATE: (B)(6) 2025. THE TEMPERATURE WAS 82.9 °F, NO FAULT FOUND. THE SPECIFICATIONS STATE THE TEMPERATURE IS NOT TO EXCEED 118.4°F. (PER FRS-9175 REV 9). ALLEGED EVENT: CONFIRMED - NOT CONFIRMED. RETURN QTY. 1, (B)(4), 30K FSI-SLI-1000-44, 00122920 BUL PER MANUFACTURE DATE. TEST METHOD / GP005-WI02: INDUCTANCE: GAUGE ID# 5349 DUE: (B)(6) 2026 RESULT 3.05. 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: (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 HAS A HP SEALING RING WATER LEAK. INSERT WAS TESTED ON A DIGITAL THERMOMETER I.D.#6116A. DUE DATE: (B)(6) 2025. THE TEMPERATURE WAS 79.6 °F, NO FAULT FOUND. THE SPECIFICATIONS STATE THE TEMPERATURE IS NOT TO EXCEED 118.4°F. (PER FRS-9175 REV 9). ALLEGED EVENT: CONFIRMED NOT CONFIRMED. RETURN QTY. 1, (B)(4), 30K FSI-SLI-1000-44, 00122920 BUL PER MANUFACTURE DATE. TEST METHOD / GP005-WI02 - INDUCTANCE: GAUGE ID# 5349 DUE: (B)(6) 2026 RESULT 3.09. 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: (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.# 6116A. DUE DATE: (B)(6) 2025. THE TEMPERATURE WAS 85.4 °F, NO FAULT FOUND. THE SPECIFICATIONS STATE THE TEMPERATURE IS NOT TO EXCEED 118.4°F. (PER FRS-9175 REV 9). ALLEGED EVENT: CONFIRMED NOT CONFIRMED RETURN QTY. 1, (B)(4), 30K FSI-SLI-1000-44, 00122920 BUL PER MANUFACTURE DATE. TEST METHOD / GP005-WI02 : INDUCTANCE: GAUGE ID# 5349 DUE: (B)(6) 2026 RESULT 3.09. 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: (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.#6116A. DUE DATE: (B)(6) 2025. THE TEMPERATURE WAS 85.4 °F, NO FAULT FOUND. THE SPECIFICATIONS STATE THE TEMPERATURE IS NOT TO EXCEED 118.4°F. (PER FRS-9175 REV 9). ALLEGED EVENT: CONFIRMED NOT CONFIRMED. RETURN QTY. 1, (B)(4), 30K FSI-SLI-1000-44, 00122920 BUL PER MANUFACTURE DATE. TEST METHOD / GP005-WI02 : INDUCTANCE: GAUGE ID# 5349 DUE: (B)(6) 2026 RESULT 3.09. 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: (B)(6) 2025 SET PRESSURE: 35 PSI. WATER FLOW: OUTPUT RATE: 35 PSI MEETS SPEC DOES NOT MEET SPEC N/A. SPRAY: MEETS SPECDOES 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.# 6116A. DUE DATE: (B)(6) 2025. THE TEMPERATURE WAS 85.4 °F, NO FAULT FOUND. THE SPECIFICATIONS STATE THE TEMPERATURE IS NOT TO EXCEED 118.4°F. (PER FRS-9175 REV 9). ALLEGED EVENT: CONFIRMED NOT CONFIRMED. RETURN QTY. 1, (B)(4), 30K FSI-SLI-1000-44, 00122920 BUL PER MANUFACTURE DATE. TEST METHOD / GP005-WI02: INDUCTANCE: GAUGE ID# 5349 DUE: (B)(6) 2026 RESULT 3.09. 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: (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 HAS A HP SEALING RING WATER LEAK, APPEARS TO BE MISSING THE SEALING RING. ALLEGED EVENT: CONFIRMED NOT CONFIRMED.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT,PKD ALLEGEDLY GET HOT AND THERE IS A WATER ISSUE. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238619 30K FSI-SLI-1000 INSERT,PKD SCALER, ULTRASONIC ELC DENTSPLY LLC 00122920

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown