BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONENDO OMNICLEAN (GENTLEWAVE) ENDOTHERAPYSYSTEM

    MDR report key: 4600538 · Received March 10, 2015

    Report

    Report Number
    3010817521-2015-00005
    Event Type
    Malfunction
    Date Received
    March 10, 2015
    Date of Event
    February 16, 2015
    Report Date
    March 9, 2015
    Manufacturer
    SONENDO INC.
    Product Code
    ELC
    PMA / PMN Number
    K133752
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER SERVICED THE DEVICE IN QUESTION AT THE ENDODONTIST'S OFFICE. THE ENGINEER DISCOVERED THAT THE FLUID BOTTLE (MALE) CONNECTOR WAS OBSTRUCTED WHICH INTERRUPTED FLUID DELIVERY INTO THE SYSTEM. THE ENGINEER REPLACED THE MALE CONNECTOR WITH A "NEW FROM STOCK" PART AND SUBSEQUENTLY RAN MULTIPLE CYCLES TO ENSURE THE APPROPRIATE VOLUME OF FLUID WAS BEING DELIVERED TO THE SYSTEM. AFTER THE COMPONENT WAS REPLACED, A SYSTEM TEST WAS CONDUCTED AND RESULTED IN THE SYSTEM PERFORMING WITHIN SPECIFICATION. THIS SERVICE ACTIVITY IS CONSISTENT WITH SONENDO'S PREVENTIVE MAINTENANCE PLAN FOR THE SYSTEM FLUID BOTTLES.

    Description of Event or Problem · 1

    DURING PRE-TREATMENT PREPARATION OF THE SONENDO OMNICLEAN GENTLEWAVE SYSTEM FOR USE IN ROOT CANAL THERAPY, IT WAS OBSERVED BY THE ENDODONTIST THAT THE EXPECTED VOLUME OF FLUID UTILIZED DURING PREPARATION OF THE SYSTEM WAS NOT CONSUMER. THE SYSTEM WAS NOT USED ON THE PATIENT. NO PATIENT INJURY WAS REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166052 SONENDO OMNICLEAN (GENTLEWAVE) ENDOTHERAPYSYSTEM ULTRASONIC SCALER ELC SONENDO INC. FG-006-00001 W2014092902

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR