BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONENDO OMNICLEAN (GENTLEWAVE) ENDOTHERAPY SYSTEM

    MDR report key: 4600525 · Received March 10, 2015

    Report

    Report Number
    3010817521-2015-00001
    Event Type
    Malfunction
    Date Received
    March 10, 2015
    Date of Event
    February 10, 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 A COMPONENT OF THE FLUID BOTTLE (FEMALE) CONNECTOR WAS BROKEN, WHICH INTERRUPTED FLUID DELIVERY INTO THE SYSTEM. THE ENGINEER SIMULATED THE FAILURE BY RUNNING THREE TREATMENT CYCLES OF THE SYSTEM TO COMPLETION. THE CYCLES VERIFIED THE USER'S DESCRIPTION OF THE EVENT. THE FEMALE CONNECTOR WITH "NEW FROM STOCK" PARTS AND SUBSEQUENTLY RAN MULTIPLE CYCLES TO ENSURE THE APPROPRIATE VOLUME OF FLUID WAS BEING DELIVERED TO THE SYSTEM. AFTER THE COMPONENTS WERE 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

    AFTER COMPLETION OF ROOT CANAL THERAPY WITH THE SONENDO OMNICLEAN GENTLEWAVE SYSTEM, IT WAS OBSERVED BY THE ENDODONTIST THAT THE EXPECTED VOLUME OF TREATMENT FLUID WAS NOT CONSUMED. NO PT INJURY WAS REPORTED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166051 SONENDO OMNICLEAN (GENTLEWAVE) ENDOTHERAPY SYSTEM ELC SONENDO INC. FG-006-00001 W2014111303

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR