BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 18387268 · Received December 22, 2023

    Report

    Report Number
    9610595-2023-20219
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    December 3, 2023
    Report Date
    February 14, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170436734
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 WAS UNABLE TO BE IDENTIFIED AND DEVIATION FROM INSTRUCTION FOR USE (IFU) ARE UNKNOWN FROM THE INFORMATION PROVIDED. FURTHERMORE, PHYSICAL DAMAGE AT THE MATERIAL RESIDUE POINTS WAS NOT CONFIRMED. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. THE EVENT CAN BE DETECTED AND PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE (IFU) SECTIONS: DETECTION METHODS ARE WRITTEN IN IFU: GIF/CF/PCF-190 SERIES OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION. PREVENTION MEASURES ARE WRITTEN IN IFU: GIF/CF/PCF-190 SERIES REPROCESSING MANUAL CHAPTER 5 REPROCESSING THE ENDOSCOPE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE EVALUATION, IT WAS DETERMINED THAT FOREIGN MATERIAL WAS PRESENT IN THE AIR/WATER TUBE, AIR/WATER CYLINDER, AND JET TUBE. ADDITIONALLY, THE EVALUATION REVEALED THE FOLLOWING FINDINGS: PLUG UNIT WAS DAMAGED; ADHESIVE ON DISTAL END COVER HAD WEAR; DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN UP DIRECTION DID NOT MEET THE STANDARD VALUE; AND DUE TO CLOGGING OF JET TUBE IN CONTROL UNIT, WATER COULD NOT BE SUPPLIED. THE INVESTIGATION IS ONGOING AND FOLLOW-UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS A MALFUNCTION AT BUTTON NUMBER 1 (CAN NO LONGER FREEZE THE IMAGE) ON THE GASTROINTESTINAL VIDEOSCOPE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING TESTING AND INSPECTION OF THE DEVICE, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: WHITE FOREIGN MATERIAL, WHICH HAS BEEN ATTRIBUTED TO INSUFFICIENT CLEANING. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570049 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170436734

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown