BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DSD EDGE ENDOSCOPE REPROCESSING SYSTEM

    MDR report key: 12968029 · Received December 9, 2021

    Report

    Report Number
    2150060-2021-00028
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 9, 2021
    Report Date
    December 8, 2021
    Manufacturer
    MEDIVATORS, INC.
    Product Code
    FEB
    UDI-DI
    00677964046674
    PMA / PMN Number
    K092387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY CONTACTED MEDIVATORS REGARDING THE DISPLAY PANEL OF THEIR DSD EDGE ENDOSCOPE REPROCESSING SYSTEM. DURING TROUBLESHOOTING WITH THE MEDIVATORS TECHNICAL SERVICE REPRESENTATIVE (TSR), IT WAS IDENTIFIED THAT DETERGENT WAS LEAKING WITHIN THE UNIT. THE MEDIVATORS TSR ADVISED THE USER FACILITY TO UNPLUG THE UNIT AND DISPATCHED A MEDIVATORS FIELD SERVICE ENGINEER (FSE) TO GO ON-SITE TO EVALUATE THE UNIT. THE FOLLOWING DAY, THE FSE ARRIVED ON SITE AND IDENTIFIED A BURNING SMELL AND THE GROUND FAULT INTERRUPTOR COVERED IN BLACK MATTER. THE USER FACILITY EXPLAINED THAT THE PREVIOUS DAY, FOLLOWING THE MEDIVATORS TSR INSTRUCTION TO UNPLUG THE UNIT, THE FACILITY CONTINUED TO OPERATE IT. DURING OPERATION, A POP SOUND OCCURRED, AND A SPARK AND SMOKE WAS OBSERVED. THE FIRE DEPARTMENT WAS CALLED, AND THE UNIT WAS REMOVED FROM SERVICE. THE DSD EDGE 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 AER SUBJECT OF THIS REPORT WAS MANUFACTURED IN FEBRUARY 2011 MAKING IT OVER 10 YEARS OLD. NO PATIENT OR USER HARM WAS REPORTED AS A RESULT OF THIS EVENT. DUE TO THE CONDITION OF THE UNIT, THE ROOT CAUSE OF THE SITUATION COULD NOT BE CONFIRMED. THE USER FACILITY HAS ORDERED A NEW ENDOSCOPE REPROCESSING SYSTEM AS REPLACEMENT.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED THAT THEIR DISPLAY PANEL ON THEIR DSD EDGE ENDOSCOPE REPROCESSING SYSTEM WAS NOT FUNCTIONING AND DETERGENT APPEARED TO BE LEAKING IN THE UNIT. MEDIVATORS TECHNICAL SERVICE ADVISED THE CUSTOMER TO UNPLUG THE UNIT FROM THE WALL AND DISPATCHED A MEDIVATORS FIELD SERVICE ENGINEER TO GO ON-SITE TO EVALUATE THE UNIT. NO PATIENT OR USER HARM WAS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1865360 DSD EDGE ENDOSCOPE REPROCESSING SYSTEM DSD EDGE 120 V FEB MEDIVATORS, INC. 78400-402 00677964046674

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown