BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT

    MDR report key: 8801154 · Received July 17, 2019

    Report

    Report Number
    2424472-2019-00112
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Report Date
    September 30, 2019
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    QTY 4 INSERTS RETURNED NOT IN ORIGINAL CLAM SHELL. VIBRATION. QTY 1 OF 4, INSERT 1 OF 4: P/N 1823234 QTY 4 INSERTS RETURNED NOT IN ORIGINAL CLAM SHELL. P/N 80395 DATE CODE: 18096,00004018 TIP LOT # HY. TEMPERATURE GAUGE: 7969 DUE 11/30/2019. TEMP: 87.4 MEETS SPEC. INDUCTANCE : 3.14MEETS SPEC. TIP CONDITION: BENT TIP DOES NOT MEET SPEC. STACK CONDITION: MEETS SPEC. TESTED ON: G-136 GAGE ID# 9626DUE DATE: 04/30/20. SET PRESSURE: 35+-5 PSI WATER FLOW RATE: 35 PSI MEETS SPEC. SPRAY PATTERN: MEETS SPEC. WATER LEAK: MEETS SPEC. VIBRATION : MEETS SPEC. GRIP CONDITION: MEETS SPEC. INSERT 2 OF 4: P/N 1823234 QTY 4 INSERTS RETURNED NOT IN ORIGINAL CLAM SHELL. P/N 80395 DATE CODE: 18096,00004018 TIP LOT # HY. COULD NOT TEST INSERT IS CLOGGED DOES NOT MEET SPEC. INDUCTANCE : 3.09MEETS SPEC. TIP CONDITION: BENT TIP DOES NOT MEET SPEC. STACK CONDITION: SLIGHT BENT IN LAMINATION STACK DOES NOT MEET SPEC. TESTED ON: G-136 GAGE ID# 9626, DUE DATE: 04/30/2020. SET PRESSURE: 35+-5 PSI WATER FLOW RATE: 0PSI DOES NOT MEET SPEC. SPRAY PATTERN: N / A INSERT IS CLOGGED. WATER LEAK: N/ A INSERT IS CLOGGED. VIBRATION : MEETS SPEC. GRIP CONDITION: MEETS SPEC. INSERT 3 OF 4: P/N 1823234 QTY 4 INSERTS RETURNED NOT IN ORIGINAL CLAM SHELL. P/N 80395 DATE CODE: 18096,00004018 TIP LOT # HY. TEMPERATURE GAUGE: 7969 DUE 11/30/2019. TEMP: 80.3 MEETS SPEC. INDUCTANCE : 3.05MEETS SPEC. TIP CONDITION: BENT TIP DOES NOT MEET SPEC. STACK CONDITION: SLIGHT BENT IN LAMINATION STACK DOES NOT MEET SPEC. TESTED ON: G-136 GAGE ID# 9626, DUE DATE: 04/30/2020, SET PRESSURE: 35+-5 PSI WATER FLOW RATE: 35 PSI MEETS SPEC. SPRAY PATTERN: MEETS SPEC. WATER LEAK: MEETS SPEC VIBRATION : MEETS SPEC. GRIP CONDITION: MEETS SPEC. INSERT 4 OF 4 : P/N 80395 DATE CODE: 19144,00027893 TIP LOT # IM. TEMPERATURE GAUGE: 7969 DUE 11/30/2019. TEMP: 89.2 MEETS SPEC. INDUCTANCE : 2.97MEETS SPEC. TIP CONDITION: MEETS SPEC. STACK CONDITION: SLIGHT BEND IN LAMINATION STACK DOES NOT MEET SPEC. TESTED ON: G-136 GAGE ID# 9626, DUE DATE: 04/30/2020, SET PRESSURE: 35+-5 PSI WATER FLOW RATE: 35 PSI MEETS SPEC. SPRAY PATTERN: MEETS SPEC. WATER LEAK: MEETS SPEC VIBRATION : MEETS SPEC. GRIP CONDITION: MEETS SPEC.

    Additional Manufacturer Narrative · 1

    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. THIS REPORT IS FOR THE SECOND DEVICE. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR 30K FSI-SLI-10S INSERT TIPS WERE HEATING UP; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591949 30K FOCUSED SPRAY SLIMLINE ULTRASONIC INSERT - 10S STRAIGHT SCALER, ULTRASONIC ELC DENTSPLY LLC NA 18096

    Patients

    Seq Age Sex Outcome Treatment
    1