BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 17279003 · Received July 7, 2023

    Report

    Report Number
    9610595-2023-09837
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 5, 2023
    Report Date
    September 25, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170202308
    PMA / PMN Number
    K011151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER¿S ALLEGATION OF WATER DAMAGE ON THE PLUG CONNECTOR WAS NOT CONFIRMED. HOWEVER, A STICKY FOREIGN MATERIAL WITH DUST WAS FOUND GRABBED TO THE GRIP UNIT. AT THE PLASTIC DISTAL END COVER (C-COVER)WAS FOUND A BROWN FOREIGN MATERIAL WHICH IS MOST LIKELY TRACES THAT REMAINS FROM PREVIOUS PROCEDURES. ADDITIONALLY, THE FOLLOWING EVENTS ARE AS FOLLOWS: (A.) DUE TO WEAR OF FE LEVER, U/D KNOB CANNOT BE LOCKED SECURELY, (B.) DUE TO SHORTCUT OF SWITCH CABLE, CONTROL UNIT GETS WARM, (C.) SCOPE COVER PLATE WAS DETACHED, (D.) THE GRIP HAD A SCRATCH, (E.) THE CONTROL UNIT HAD A SCRATCH, (F.) THE SUCTION COVER HAD A SCRATCH, (G.) THE SWITCH BOX HAD A SCRATCH, (H.) THE AIR/ WATER CYLINDER HAD DISCOLORATION, (I.) THE UP/DOWN KNOB HAD A SCRATCH, (J.) THE RIGHT/ LEFT KNOB HAD A SCRATCH, (K.) THE FORCEPS CHANNEL PORT HAD A DENT, (L.) THE LABEL ON THE SUCTION CONNECTOR WAS PEELED, (M.) THE SCOPE CONNECTOR COVER UNIT HAD A SCRATCH, (N.) THE SUCTION CONNECTOR HAD A SCRATCH, (N.) THE CHARGED CABLED DEVICE UNIT CIRCUIT BOARD HAD CORROSION DUE TO WATER LEAKAGE, (O.) THE ELECTRONIC EXPORT INFORMATION ON THE FLEXIBLE CIRCUIT BOARD HAD CORROSION DUE TO WATER LEAKAGE, (P.) THE ELECTRICAL CONNECTOR HAD CORROSION DUE TO WATER LEAKAGE, (Q.) THE SHIELD PLATE HAD CORROSION DUE TO WATER LEAKAGE, (R.) THE SHIELD DISC HAD CORROSION DUE TO WATER LEAKAGE, (S.) DUE TO CORROSION ON THE ELECTRICAL CONNECTOR, A NOISE IMAGE OCCURRED, (T.) DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN UP DIRECTION DOES NOT MEET THE STANDARD VALUE, (U.) THE PLASTIC DISTAL END COVER HAD FOREIGN OBJECTS, (V.) THE OBJECTIVE LENS HAD A CRACK, (W.) THE LIGHT GUIDE LENS HAD A CRACK, (X.) AND THE UNIVERSAL CORD HAD A SCRATCH. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    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, THE FOREIGN MATERIAL COULD NOT BE IDENTIFIED NOR THE ROOT CAUSE OF IT. THE EVENT CAN BE DETECTED/PREVENTED BY HANDLING DEVICE IN ACCORDANCE WITH THE FOLLOWING INSTRUCTIONS FOR USE: OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION REPROCESSING MANUAL CHAPTER 5 REPROCESSING THE ENDOSCOPE OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE, EXPERIENCED WATER DAMAGE IN THE PLUG. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT OR USER HARM ASSOCIATED WITH THE EVENT. SUBSEQUENTLY, OLYMPUS DISCOVERED A STICKY FOREIGN MATERIAL WITH DUST WAS FOUND GRABBED TO THE GRIP UNIT. AT THE PLASTIC DISTAL END COVER (C-COVER) WAS FOUND A BROWN FOREIGN MATERIAL WHICH IS MOST LIKELY TRACES THAT REMAINS FROM PREVIOUS PROCEDURES. THIS MEDWATCH REPORT IS BEING SUBMITTED TO CAPTURE THIS REPORTABLE MALFUNCTION WHICH WAS IDENTIFIED DURING THE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498233 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-Q165 04953170202308

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown