BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR

    MDR report key: 16638185 · Received March 29, 2023

    Report

    Report Number
    2150060-2023-00018
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    March 4, 2023
    Report Date
    March 29, 2023
    Manufacturer
    MEDIVATORS INC
    Product Code
    FEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT THE INTERNAL DRAIN LINE WAS DAMAGED AND LEAKED ONTO THE GROUND FAULT INTERRUPTER OUTLET (GFI). AS THE DRAIN LINE LEAKED ONTO THE GFI, THE GFI SUSTAINED ELECTRICAL DAMAGE RESULTING IN THE REPORTED EVENT. THE DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR 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 COUNSELED USER FACILITY PERSONNEL ON THE IMPORTANCE OF FOLLOWING PROPER PREVENTIVE MAINTENANCE ACTIVITIES. THE UNIT HAS BEEN REMOVED FROM SERVICE. DUE TO THE DAMAGE SUSTAINED, STERIS IS WORKING TO PROVIDE THE CUSTOMER A QUOTE FOR A NEW UNIT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THEY HEARD A "POP" NOISE AND OBSERVED SMOKE EMITTING FROM THEIR DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087601 DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR AUTOMATED ENDOSCOPE REPROCESSOR FEB MEDIVATORS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown