BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17548043 · Received August 15, 2023

    Report

    Report Number
    2424472-2023-00399
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Report Date
    November 2, 2023
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D003820061
    PMA / PMN Number
    K052334/K970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FAILURE MODE: OVERHEATING INSERT. ROOT CAUSE: TIP/NOZZLE CORRODED (RUST) 1) TIP CORRODED (RUST) / ALSO INSERT WAS TESTED ON A DIGITAL THERMOMETER I.D.# (B)(6), DUE DATE: 09/30/2023. THE TEMPERATURE WAS 92.7° F, NO FAULT FOUND. THE SPECIFICATION STATES ARE NOT TO EXCEED 118.4°F. (PER (B)(4)). 2) TIP CORRODED (RUST) / ALSO INSERT WAS TESTED ON A DIGITAL THERMOMETER I.D.# (B)(6), DUE DATE: 09/30/2023. THE TEMPERATURE WAS 89.5° F, NO FAULT FOUND. THE SPECIFICATION STATES ARE NOT TO EXCEED 118.4°F. (PER (B)(4)). RETURNED QTY.2 INSERTS, 1. 80396, 22236-00081988, 54, BUL. TEST METHOD / GP005-WI02. INDUCTANCE: GAUGE ID# 5349, DUE: 11/30/2024, RESULT: 3.20. ¿ 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# (B)(4), 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 TIP IS RUSTY. ALSO INSERT WAS TESTED ON A DIGITAL THERMOMETER I.D.#6116A DUE DATE: 09/30/2023. THE TEMPERATURE WAS 92.7° F, NO FAULT FOUND. THE SPECIFICATION STATES ARE NOT TO EXCEED 118.4°F. (PER FRS-9175). ALLEGED EVENT: ¿ CONFIRMED - ¿ NOT CONFIRMED. ¿ 2. 80396, 22236-00081988, 54, BUL. TEST METHOD / GP005-WI02 INDUCTANCE: GAUGE ID# 5349 DUE: 11/30/2024 RESULT: 3.20 ¿ 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 TIP IS RUSTY. ALSO INSERT WAS TESTED ON A DIGITAL THERMOMETER I.D.#6116A DUE DATE: 09/30/2023. THE TEMPERATURE WAS 89.5° 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

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR 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-FG-10L INS, PKD GOT HOT DURING USE. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995244 30K FSI-SLI-FG-10L INS,PKD SCALER, ULTRASONIC ELC DENTSPLY LLC 00081988 D003820061

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown