BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GASTROINTESTINAL VIDEOACOPE

    MDR report key: 14659892 · Received June 10, 2022

    Report

    Report Number
    8010047-2022-09884
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 9, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170312373
    PMA / PMN Number
    K111756
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE MET ALL SPECIFICATIONS AT THE TIME OF SHIPMENT. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, IT IS LIKELY THE NOZZLE WAS CLOGGED WITH FOREIGN MATTER (SUCH AS BODY FLUIDS, ETC.) DUE TO IMPROPER REPROCESSING OF THE DEVICE AFTER THE PREVIOUS PROCEDURE. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE FOLLOWING INFORMATION IS PROVIDED IN THE DEVICE'S INSTRUCTIONS FOR USE REGARDING THE IDENTIFICATION OF THE ISSUE: "INSPECT THE AIR/WATER NOZZLE AT THE DISTAL END OF THE ENDOSCOPE¿S INSERTION SECTION FOR ABNORMAL SWELLING, BULGES, DENTS, OR OTHER IRREGULARITIES." THE FOLLOWING INFORMATION IS PROVIDED IN THE REPROCESSING MANUAL THAT MAY HELP TO REDUCE OR PREVENT THE ISSUE: "WARNING: IF THE ENDOSCOPE AND ACCESSORIES USED IN THE PATIENT PROCEDURE ARE NOT IMMEDIATELY CLEANED AFTER EACH PATIENT PROCEDURE, RESIDUAL ORGANIC DEBRIS WILL BEGIN TO DRY AND SOLIDIFY, HINDERING EFFECTIVE REMOVAL AND REPROCESSING EFFICACY. PRECLEAN THE ENDOSCOPE AND THE ACCESSORIES AT THE BEDSIDE IMMEDIATELY AFTER EACH PATIENT PROCEDURE." "CAUTION: TO PREVENT CLOGGING OF THE AIR/WATER NOZZLE OF THE ENDOSCOPE, FLUSH WATER INTO THE AIR CHANNEL OF THE ENDOSCOPE, USING THE AW CHANNEL CLEANING ADAPTER (MH-948) AFTER EACH PATIENT PROCEDURE." REGARDING MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES: "-CLEAN THE EXTERNAL SURFACE. -IMMERSE THE ENDOSCOPE IN THE DETERGENT SOLUTION. -THOROUGHLY BRUSH OR WIPE ALL EXTERNAL SURFACES OF THE ENDOSCOPE, USING CLEAN LINT-FREE CLOTHS, BRUSHES, OR SPONGES. PAY PARTICULAR ATTENTION TO THE AIR/WATER NOZZLE OPENING AND THE OBJECTIVE LENS ON THE DISTAL END OF THE INSERTION SECTION, AND CONFIRM THAT ALL DEBRIS IS REMOVED FROM ALL SURFACES OF THE DISTAL END. -FLUSH THE AIR/WATER CHANNEL WITH DETERGENT SOLUTION. -REMOVE DETERGENT SOLUTION FROM ALL CHANNELS." "IF THERE WAS EXCESSIVE BLEEDING DURING THE PATIENT PROCEDURE OR IF PRECLEANING COULD NOT BE PERFORMED IMMEDIATELY AFTER THE PATIENT PROCEDURE, PRESOAKING THE ENDOSCOPE IN DETERGENT SOLUTION BEFORE MANUALLY CLEANING THE ENDOSCOPE MAY BE REQUIRED TO WET AND LOOSEN DEBRIS THAT HAS DRIED AND HARDENED ONTO THE ENDOSCOPE¿S SURFACES." THE REPORTED ISSUE (REDUCED ANGULATION) WAS CONFIRMED AND FOUND TO BE CAUSED BY WEAR OF THE ANGULATION WIRE. IN ADDITION, SERVICE FOUND THERE WAS A LEAKAGE DUE TO DEFORMATION OF THE RIGHT/LEFT ANGULATION KNOB, THERE WAS A LEAKAGE DUE TO DEFORMATION OF THE UP/DOWN ANGULATION KNOB, AND THERE WAS A LEAKAGE DUE TO DEFORMATION OF THE VIDEO CONNECTOR. THE NOZZLE WAS DEFORMED, THE OBJECTIVE LENS WAS SCRATCHED, THE DISTAL END WAS SCRATCHED AND SHAVED, THE ADHESIVE ON THE BENDING SECTION COVER WAS DETACHED, THERE WAS CLOTTING PROTEIN ON THE BENDING SECTION COVER, THE COATING ON THE CONNECTING TUBE WAS PEELED OFF, THE CONNECTING TUBE WAS DIRTY AND DENTED, THE GRIP WAS DIRTY, SWITCH BUTTON #1 WAS CUT, THE RIGHT/LEFT AND UP/DOWN ANGULATION KNOBS WERE DIRTY, THE VIDEO CONNECTOR WAS CRACKED, THE CONTROL UNIT WAS DIRTY, THE BENDING TUBE WAS DENTED, THE SCOPE CONNECTOR COVER WAS DIRTY, THE SCOPE CONNECTOR WAS CRACKED, THERE WAS PLAY IN THE ANGULATION KNOBS DUE TO WEAR OF THE ANGULATION WIRE, THE CHANNEL CLEANING BRUSH COULD NOT BE SMOOTHLY INSERTED DUE TO A DENTED FORCEPS CHANNEL, AND THE WATER REMOVAL ABILITY WAS OUT OF SPECIFICATION DUE TO THE DEFORMED NOZZLE. PER THE LEGAL MANUFACTURER, THESE OTHER DEVICE ISSUES FOUND BY SERVICE HAVE NO POTENTIAL TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTIONS WERE TO RECUR. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION THAT WAS RECEIVED FROM THE USER FACILITY REGARDING THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER'S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS 9610595.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE SUBJECT DEVICE WAS EXHIBITING REDUCED ANGULATION. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THE AIR/WATER NOZZLE WAS CLOGGED WITH FOREIGN MATERIAL. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION OF THE DEVICE (FOREIGN MATERIAL). ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY REGARDING THE REPORTED EVENT (REDUCED ANGULATION): THE REPORTED ISSUE WAS OBSERVED DURING GENERAL/ ROUTINE INSPECTION OF THE SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309509 GASTROINTESTINAL VIDEOACOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-LV1 04953170312373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown