BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12381181 · Received August 28, 2021

    Report

    Report Number
    8010047-2021-10881
    Event Type
    Injury
    Date Received
    August 28, 2021
    Date of Event
    July 7, 2021
    Report Date
    May 6, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305290
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THE REPORTED PHENOMENON (CLOGGING OF THE AIR/WATER NOZZLE). THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE FURTHER INFORMATION FROM THE LEGAL MANUFACTURER'S FINAL INVESTIGATION PER CAPA-200413. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, ALTHOUGH FOREIGN MATERIAL WAS CONFIRMED, THE SPECIFIC MATERIAL COULD NOT BE IDENTIFIED. IT COULD NOT BE DETERMINED IF THE REPROCESSING METHOD DEVIATED FROM THE INSTRUCTIONS FOR USE (IFU). THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE IFU STATE: ¿PRECAUTIONS: WARNING DO NOT STRIKE, HIT, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, OR ENDOSCOPE CONNECTOR OF THE ENDOSCOPE. ALSO, DO NOT BEND, PULL, OR TWIST THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, OR ENDOSCOPE CONNECTOR OF THE ENDOSCOPE WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, BURNS, BLEEDING, AND/OR PERFORATIONS. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT. ¿ ¿PRECAUTIONS: WARNING NEVER INSERT OR WITHDRAW THE ENDOSCOPE UNDER ANY OF THE FOLLOWING CONDITIONS. PATIENT INJURY, BLEEDING, AND/OR PERFORATION CAN RESULT. WHILE THE ENDOTHERAPY ACCESSORY EXTENDS FROM THE DISTAL END OF THE ENDOSCOPE. WHILE THE BENDING SECTION IS LOCKED IN POSITION. INSERTION OR WITHDRAWAL WITH EXCESSIVE FORCE. WHILE THE IMAGE IS ELECTRONICALLY ZOOMED USING THE FUNCTION OF THE VIDEO SYSTEM CENTER. ¿ ¿OPERATION MANUAL SAYS ABOUT INSPECTION OF DEVICE AS BELOW: INSPECTION OF THE ENDOSCOPE INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION SECTION INCLUDING THE BENDING SECTION AND THE DISTAL END FOR ANY IRREGULARITIES SUCH AS DENTS, BULGES, SWELLING, SCRATCHES, PEELING OF COATING, HOLES, SAGGING, TRANSFORMATION, BENDS, ADHESION OF FOREIGN BODIES, MISSING PARTS, AND PROTRUDING OBJECTS. INSPECT THE AIR/WATER NOZZLE AT THE DISTAL END OF THE ENDOSCOPE FOR ANY IRREGULARITIES SUCH AS ABNORMAL SWELLING, BULGES, AND DENTS.¿ ¿INSPECTION OF THE ENDOSCOPIC SYSTEM INSPECTION OF THE OBJECTIVE LENS CLEANING FUNCTION INSPECTION OF REMOVING THE REMAINING WATER FROM THE OBJECTIVE LENS AFTER CHECKING THE WATER FEEDING FUNCTION AND WHILE OBSERVING THE ENDOSCOPIC IMAGE, FEED AIR BY COVERING THE HOLE IN THE AIR/WATER VALVE WITH YOUR FINGER. CONFIRM THAT THE EMITTED AIR REMOVES THE REMAINING WATER FROM THE OBJECTIVE LENS AND CLEARS THE ENDOSCOPIC IMAGE.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON THAT THE PATIENT'S INJURY COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE REPORTED INFORMATION, IT MIGHT HAVE BEEN DUE TO USER HANDLING. ALSO THE PATIENT'S INJURY WAS MINOR, THEREFORE IT WAS NOT REPORTABLE EVENT. THE EXACT CAUSE OF THE REPORTED PHENOMENON THAT CLOGGED NOZZLE COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE REPORTED INFORMATION AND PAST SIMILAR CASE, IT WAS PRESUMED THAT DURING THE USER HANDLING SOME FOREIGN MATERIAL ENTERED CHANNEL AND AIR/WATER FEEDING MADE THE NOZZLE CLOG. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    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

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4), IT WAS FOUND THAT THE AIR/WATER NOZZLE HAD BEEN CLOGGED WITH THE FOREIGN MATERIAL. THE SUBJECT DEVICE HAD BEEN RETURNED TO (B)(4) BECAUSE THE PATIENT HAD SUFFERED MINOR INJURY OF THE DUODENUM TISSUE BY GETTING HIT WITH THE DISTAL END OF THE SUBJECT DEVICE TO THE TISSUE DURING THE DIAGNOSTIC UPPER GASTROINTESTINAL ENDOSCOPY. NO TREATMENT WAS REQUIRED FOR THE INJURY. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278598 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H190 04953170305290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown