BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA DUODENOVIDEOSCOPE

    MDR report key: 15975284 · Received December 14, 2022

    Report

    Report Number
    9610595-2022-05401
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    November 14, 2022
    Report Date
    April 24, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    PMA / PMN Number
    K024033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THIRD PARTY HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) RESULTS. THE HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) RESULTS WERE PROVIDED. RESULTS NOTED THAT ALL CHANNELS (DISTAL END, INSTRUMENT / BIOPSY / SUCTION CHANNEL/AIR/ WATER CHANNEL AND ELEVATOR WIRE CHANNEL WERE CULTURED /TESTED AND FOUND NO DETECTION OF MICROORGANISM. THE RESULTS ARE CONFORM IN ACCORDANCE WITH "RKI-BFARM-GUIDELINE. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED THE FOLLOWING HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) RESULTS (CULTURE TEST RESULTS): THE DEVICE TESTED POSITIVE WITH GRAM NEGATIVE BACILLUS: COUNTLESS COLONIES. BELOW ARE INFORMATION ON CUSTOMERS CDS CHECKLIST: CLEANING, DISINFECTION, AND STERILIZATION (CDS) - AER/EWD REPROCESSOR: NO ANSWER MODEL NAME: NO ANSWER PRE-CLEANING: ASPIRATION OF WATER THROUGH THE INSTRUMENT/SUCTION CHANNEL. FLUSHING CHANNELS : AIR/WATER (A/W) CHANNEL, AUXILIARY WATER CHANNEL, BALLOON CHANNEL , FORCEPS ELEVATOR WIRE CHANNEL. DETERGENT USED : ENZIMATICO MANUAL CLEANING : BRUSH POINTS: INSTRUMENT / SUCTION CHANNEL , SUCTION CYLINDER , INSTRUMENT CHANNEL PORT, BALLOON CHANNEL, DISTAL END AREAS AROUND ELEVATOR. BRUSH MODEL: OLYMPUS MANUAL DISINFECTION NOT PERFORMED. SCOPE STORAGE: SIMPLE CABINET WITHOUT ANY DRYING FUNCTION. THE DEVICE INSPECTION AND EVALUATION FINDINGS AT OLYMPUS REPAIR CENTER NOTED LEAKAGE FROM A-RUBBER AND DISTAL END ARE DETECTED. THE CUSTOMER REPORTED ISSUE WHEN DEVICE WAS SENT FOR REPAIR OF "LEAKAGE" WAS CONFIRMED. ADDITIONAL FINDINGS INCLUDES : CUT ON CCD CABLE OBSERVED. AW-CYLINDER HAS DISCOLORATION. EL-CONNECTOR IS DAMAGED. ADHESIVE ON A-RUBBER HAS WEAR. CONNECTING TUBE HAS A BUCKLING. LG LENS HAS A CHIP. DUE TO A CRACK ON DISTAL END, WATER TIGHTNESS IS LOST. DUE TO A PINHOLE ON A-RUBBER, WATER TIGHTNESS IS LOST. DUE TO DEFORMATION OF BENDING TUBE, BENDING ANGLE IN RIGHT DIRECTION DOES NOT MEET THE STANDARD VALUE. OLYMPUS HMI TESTING RESULTS HAS NOT YET BEEN RECEIVED FOR EVALUATION. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON CUSTOMER FOLLOW UP RESPONSE. COMMUNICATION AND FOLLOW UP RESPONSE CONVEYED THE FOLLOWING: NO FURTHER INFORMATION HAS BEEN RECEIVED RELATED TO INFECTION ON PATIENTS. NO OTHER INFORMATION WAS PROVIDED. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED SHOULD ANY RELEVANT NEW INFORMATION IS AVAILABLE. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. GROWTH OF MICROORGANISMS WERE FOUND THROUGH CULTURE TESTING BY THE USER AFTER REPROCESSING. HOWEVER, WHEN OLYMPUS CULTURE TESTED AFTER REPROCESSING IN ACCORDANCE WITH INSTRUCTIONS FOR USE (IFU) BEFORE REPAIR, THE RESULTS CONFORMED TO THE REGULATION'S RECOMMENDATION. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    A HYGIENE MICROBIOLOGICAL INVESTIGATION (HMI) REPORT (POSITIVE IN A CULTURE TEST) WAS RECEIVED FROM THE CUSTOMER AFTER THE DEVICE WAS SENT TO SERVICE REPAIR CENTER FOR THE ISSUE OF "LEAKAGE" ACCORDING TO THE REPORT, ON THE 15TH NOVEMBER, THE UPTIME MANAGER OLYMPUS REPRESENTATIVE RECEIVED A CALL FROM CUSTOMER REPORTING A POSITIVE IN A CULTURE TEST .THE DEVICE WAS ALREADY AT SERVICE CENTER OLYMPUS IBERIA (OIB) WORKSHOP SINCE CUSTOMER HAD SENT IT FOR REPAIR DUE TO A LEAKAGE. THE OLYMPUS TERRITORY MANAGER CONTACTED THE CUSTOMER IN ORDER TO CONFIRM IF THERE ARE PATIENTS INFECTED. ACCORDING TO THE INFORMATION PROVIDED BY CUSTOMER, "THERE IS A POSSIBILITY OF INFECTED PATIENTS BUT NOT CONFIRMED". THERE ARE NO KNOWN PATIENT INFECTION ASSOCIATED ON THE EVENT REPORTED. NO HARM REPORTED, NO PATIENT INJURY, NO USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474470 EVIS EXERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-160VR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown