BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20133988 · Received September 4, 2024

    Report

    Report Number
    2424472-2024-00392
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Date of Event
    August 15, 2024
    Report Date
    September 4, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D003820051
    PMA / PMN Number
    K052334/K970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. INVESTIGATION RESULTS: RETURN QTY. 1, 22321, 30K FSI-SLI-10S-GF, 00087051 BUL 30K. TEST METHOD / GP005-WI02 INDUCTANCE: GAUGE ID (B)(4) DUE: (B)(6) 2024 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 (B)(4) DUE DATE: ON (B)(6) 2024 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 BROKEN AT THE EDM HOLE. ALLEGED EVENT: CONFIRMED - NOT CONFIRMED.

    Description of Event or Problem · 0

    IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10S INS,PKD TIP BROKE AND PATIENT SWALLOWED THE BROKEN TIP. PATIENT WAS SENT TO EMERGENCY ROOM TO LOCATE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870406 30K FSI-SLI-FG-10S INS,PKD SCALER, ULTRASONIC ELC DENTSPLY LLC 00087051 D003820051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown