BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAVITRON JET PLUS W/TAPON-115V G137(DNA)

    MDR report key: 20383068 · Received October 7, 2024

    Report

    Report Number
    2424472-2024-00088
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Report Date
    November 25, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D00381875011
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AUY PLUMBING/MANIFOLD OIL/MOISTURE UNIT HAS BEEN CROSSLINED, WATER IN THE AIR SYSTEM, CAUSING POWDER TO STICK TOGETHER AND HARDEN IN THE MANIFOLD AND BOWL ASSEMBLY, OIL/WATER CONTAMINATION IN THE AIR SUPPLY HOSE, CLOGGED DUCKBILL FILTER CAUSING POOR AIR/POWDER FLOW, CLOGGED PINCH TUBE CAUSING NO POWDER FLOW, POWDER BUILDUP IN THE BOWL AND CAP THREADS CAUSING AN AIR LEAK AND POOR POWDER FLOW. POOR WATER FLOW REGULATION, HARDENED AND DETERIORATED WATER SUPPLY HOSE, DEBRIS BUILDUP IN THE WATER FILTER. NO BATTERIES IN WIRELESS FOOT PEDAL, DAMAGED WATER FLOW CONTROL ON THE HANDPIECE CABLE, CORRODED CONTACT PINS ON THE JET-MATE HANDPIECE (# 08170). WILL REPLACE DAMAGED/WORN COMPONENTS AND RECALIBRATE UNIT TO FACTORY SPECS UPON ESTIMATE APPROVAL *LOANER FEE HAS BEEN INCLUDED IN THE ESTIMATE. 3 X HANDPIECES # : 2 X 09170, 1 X 08170. HANDPIECE CABLE # : 11170.

    Description of Event or Problem · 0

    WHILE USING A CAVITRON JET PLUS G137, THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND THE HANDPIECE IS HEATING UP, NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2543473 CAVITRON JET PLUS W/TAPON-115V G137(DNA) SCALER, ULTRASONIC ELC DENTSPLY LLC D00381875011

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown