BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAV.JET PLUS W/TAPON-115V G137

    MDR report key: 14654538 · Received June 10, 2022

    Report

    Report Number
    2424472-2022-00018
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Report Date
    June 10, 2022
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE LACK OF WATER FLOW HAS CAUSED AN OVERHEATING INSERT. 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. AFTER INSPECTION/EVALUATION OF DEVICE FOUND EMH HP;CABLE,CONN/GUN CABLE DAMAGED. HPC IS DAMAGED, RESTRICTING WATER FLOW AND VIBRATION. THE WATER HOSE IS KINKED/TWISTED, CAUSING INTERMITTENT WATER FLOW. CHECK CALIBRATIONS.

    Description of Event or Problem · 0

    EVALUATION OF THE DEVICE FOUND THE WATER HOSE WAS KINKED/TWISTED, CAUSING RESTRICTED WATER FLOW. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421075 CAV.JET PLUS W/TAPON-115V G137 SCALER, ULTRASONIC ELC DENTSPLY LLC G137

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown