BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPE REPROCESSOR

    MDR report key: 16993365 · Received May 24, 2023

    Report

    Report Number
    9610595-2023-07944
    Event Type
    Malfunction
    Date Received
    May 24, 2023
    Date of Event
    April 27, 2023
    Report Date
    May 24, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FEB
    UDI-DI
    04953170258589
    PMA / PMN Number
    K103264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOTING WITH TECHNICAL ASSISTANCE CENTER (TAC), THE CUSTOMER PERFORMED A DRAIN DISINFECTANT LCG AND THEN A LOAD LCG BUT COULD NOT CLOSE THE DOOR. THE CUSTOMER WAS RECOMMENDED TO VISIBLY INSPECT THE LOAD TRAY AND WITHIN, TO SEE IF THERE WERE ANY BLOCKAGES. AN OLYMPUS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE AND REPAIR THE DEVICE. THE FSE MANUALLY PULLED BACK THE LOCK AND CLOSED THE DRAWER, THEN DID A PROGRAM B THEN A DRAIN LCG FOLLOWED BY A LOAD LCG, AND EVERYTHING WORKED NORMALLY. THE DEVICE WAS REPAIRED AND VERIFIED ACCORDING TO ORIGINAL EQUIPMENT MANUFACTURER (OEM) INSTRUCTIONS, SOFTWARE ATTRIBUTES WERE VERIFIED AND CONFIRMED. DEVICE INVESTIGATION WAS COMPLETED WITH THE INFORMATION AVAILABLE. BASED ON THE RESULTS OF THE INVESTIGATION, THE REPORTED ISSUE WAS LIKELY DUE TO INCORRECT DETECTION BY THE SENSOR EVEN THOUGH THE DISINFECTANT BOTTLE WAS NOT INSTALLED. AS FOR THE CAUSE OF THE DETECTION, TEMPORARY CONTACT FAILURE OF CONTACTS INSIDE THE SENSOR MAY HAVE OCCURRED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. A REVIEW OF THE DHR FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), DURING REPROCESSING, THE DISINFECTANT DRAWER OF THE ENDOSCOPE REPROCESSOR COULD NOT BE CLOSED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949080 ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSOR FEB AIZU OLYMPUS CO., LTD. OER-PRO 04953170258589

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown