BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 15086429 · Received July 22, 2022

    Report

    Report Number
    9610595-2022-00208
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 22, 2022
    Report Date
    November 15, 2022
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE FOLLOWING FIELDS IN THE INITIAL MDR: BRAND NAME CHANGED TO EVIS EXERA III COLONOVIDEOSCOPE. COMMON DEVICE NAME CHANGED TO FLEXIBLE VIDEO COLONOSCOPE, REUSABLE. DEVICE PRODUCT CODE CHANGED TO FDF. MODEL # CHANGED TO PCF-H190DL. SERIAL # CHANGED TO (B)(4). UDI CHANGED TO (B)(4). PMA/510(K) NUMBER CHANGED TO K131780. THE INVESTIGATION IS ONGOING; THEREFORE, A ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    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 DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE SUGGESTED PHENOMENON WAS PRESUMED TO HAVE BEEN DUE TO THE USER¿S UNDERSTANDING DIFFERING FROM OLYMPUS RECOMMENDATION IN DEVICE HANDLING AND REPROCESSING STEP. THE INSTRUCTIONS FOR USE (IFU) (REPROCESSING MANUAL) WARNS AGAINST INSUFFICIENT REPROCESSING AS FOLLOWS. ¿1.4 PRECAUTIONS: AN INSUFFICIENTLY CLEANED, DISINFECTED OR STERILIZED ENDOSCOPE AND/OR ACCESSORIES MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO CONTACT THEM.¿ THE IFU (REPROCESSING MANUAL) STATES AT LISTS MAJ-2319 AT ¿5.3 PRECLEANING THE ENDOSCOPE AND ACCESSORIES¿ AS FOLLOWS: ¿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.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT BEING RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 0

    AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS ON-SITE PERFORMING IN-SERVICE TRAINING FOR SCOPE REPROCESSING. DURING THE VISIT, IT WAS NOTED THAT THE CUSTOMER WAS NOT USING THE AIR AND WATER CLEANING ADAPTER FOR BEDSIDE CLEANING. THE CUSTOMER USES A NON-OLYMPUS AUTOMATIC ENDOSCOPE REPROCESSOR (AER) TO REPROCESS THEIR SCOPES. IT WAS RECOMMENDED THAT THE CUSTOMER CONTACT THE MANUFACTURER OF THAT EQUIPMENT FOR PROPER USE. THERE WAS NO DEATH, INJURY, OR INFECTION REPORTED DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106346 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown