BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOGATOR BACKFLOW VALVE

    MDR report key: 12677615 · Received October 21, 2021

    Report

    Report Number
    1651395-2021-00003
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 16, 2021
    Report Date
    October 21, 2021
    Manufacturer
    MEDIVATORS, INC.
    Product Code
    FEQ
    UDI-DI
    00677964058455
    PMA / PMN Number
    K092429
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WARNINGS RELATED TO BACKFLOW ARE FROM THE ENDOGATOR TUBING AND ACCESSORIES INSTRUCTIONS FOR USE, "ENSURE THAT TUBING AND IRRIGATION FLOW IS FUNCTIONING PROPERLY. IF THERE IS ANY REASON TO BELIEVE THAT THE ENDOGATOR SYSTEM WAS CONTAMINATED, IMMEDIATELY DISCARD THE ENTIRE ENDOGATOR IRRIGATION TUBING, ACCESSORIES AND WATER BOTTLE. REPLACE WITH NEW ENDOGATOR IRRIGATION TUBING, ACCESSORIES AND UNOPENED STERILE WATER BOTTLE." IN A REVIEW OF COMPLAINT OVER THE LAST 2 YEARS, THIS IS THE ONLY REPORTED OCCURRENCE OF THIS EVENT. MEDIVATORS WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS AND TO ENSURE THE PRODUCT PERFORMS AS INTENDED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT POST-PROCEDURE, DURING THE PRE-CLEANING PROCESS, PROCEDURAL MATTER WAS OBSERVED TO BE FLOWING PAST THE MEDIVATORS ENDOGATOR BACKFLOW VALVE THROUGH THE IRRIGATION TUBING. THE REPORTED EVENT DID NOT OCCUR DURING A PATIENT PROCEDURE AND A PATIENT WAS NOT PRESENT AT THE TIME OF THE EVENT. ADDITIONALLY, NO HARM OR ADVERSE EVENT TO USER FACILITY PERSONNEL WAS REPORTED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576277 ENDOGATOR BACKFLOW VALVE ENDOGATOR BACKFLOW VALVE FEQ MEDIVATORS, INC. 100126 509488 00677964058455

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown