BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DSD EDGE ENDOSCOPE REPROCESSING SYSTEM

    MDR report key: 18587717 · Received January 26, 2024

    Report

    Report Number
    2150060-2024-00005
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    December 28, 2023
    Report Date
    January 26, 2024
    Manufacturer
    MEDIVATORS INC
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A MEDIVATORS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THE GROUND FAULT INTERRUPTER (GFI) TO BE DAMAGED. THROUGH FURTHER INSPECTION, THE TECHNICIAN FOUND THAT THE UNIT WAS LEAKING FROM THE B SIDE BASIN OVERFLOW. AS THE BASIN OVERFLOW WAS LEAKING THIS ALLOWED WATER TO LEAK ONTO THE GFI OUTLET RESULTING IN THE REPORTED EVENT. THE DSD EDGE AER HAS BEEN DESIGNED WITH FIRE-RESISTANT MATERIALS AND ANY THERMAL EVENTS WHICH OCCUR INTERNAL TO THE UNIT ARE EXPECTED TO BE CONTAINED AND NOT TO TRAVEL OUTSIDE OF THE UNIT. FURTHERMORE, THE SERVICE MANUAL PROVIDES THE FOLLOWING WARNING LANGUAGE FOR THE GFI AND POTENTIAL THERMAL EVENTS: "TO AVOID INJURY OR DEATH FROM AN ELECTRICAL INSULATION BREAKDOWN WITHIN THE UNIT, THE GFI (GROUND FAULT INTERRUPTER) CIRCUIT BREAKER SHOULD BE CHECKED FOR PROPER OPERATION ON AN ANNUAL BASIS. IF DURING THE USE OF THIS EQUIPMENT YOU SEE OR SMELL SMOKE, IMMEDIATELY DISCONNECT THE UNIT FROM THE POWER SUPPLY, DISCONTINUE USE AND CALL MEDIVATORS TECHNICAL SUPPORT." THE DSD EDGE AER IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THIS UNIT WAS INSTALLED IN 2011 MAKING IT APPROXIMATELY 12 YEARS OLD AT THE TIME OF THE REPORTED EVENT. THE TECHNICIAN MADE THE NECESSARY REPAIRS, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT SMOKE WAS EMITTING FROM INSIDE THEIR DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR (AER). NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148080 DSD EDGE ENDOSCOPE REPROCESSING SYSTEM ENDOSCOPE REPROCESSING SYSTEM FEB MEDIVATORS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown