BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FSI-SLI-10S INSERT,PKD

    MDR report key: 17958695 · Received October 18, 2023

    Report

    Report Number
    2424472-2023-00409
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    October 13, 2023
    Report Date
    January 9, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D003803951
    PMA / PMN Number
    K052334/K970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    RETURNED QTY.2 INSERTS, 1. 80798, 23121-00097456, DI, BEYOND USEFUL LIFE TEST METHOD / GP005-WI02 INDUCTANCE: GAUGE ID# 5349 DUE: 11/30/2024 RESULT: 3.19 ¿ 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: 03/31/24 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 IS GOOD, NO FAULT FOUND. ALSO INSERT WAS TESTED ON A DIGITAL THERMOMETER I.D.#6116A DUE DATE: 09/30/2024. THE TEMPERATURE WAS 89.1° F, NO FAULT FOUND. THE SPECIFICATION STATES ARE NOT TO EXCEED 118.4°F. (PER (B)(4)). ALLEGED EVENT: ¿ CONFIRMED - ¿ NOT CONFIRMED 2. 80395, 23207-00102750, KE, WARRANTY TEST METHOD / GP005-WI02. INDUCTANCE: GAUGE ID# 5349, DUE: 11/30/2024, RESULT: ¿ 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: 03/31/24 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 RETURNED UNOPENED PACKAGE APPEARS NEW. ALLEGED EVENT: ¿ CONFIRMED - ¿ NOT CONFIRMED.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-10S INSERT, PKD GOT HOT DURING USE AND NO WATER WAS COMING OUT OF STACK. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642756 30K FSI-SLI-10S INSERT,PKD SCALER, ULTRASONIC ELC DENTSPLY LLC 0097456 D003803951

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown