BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 18416736 · Received December 29, 2023

    Report

    Report Number
    9610595-2023-20559
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Report Date
    February 23, 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
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED AND CONFIRMED THAT THE AIR/WATER CYLINDER AND TUBE HAD FOREIGN OBJECTS. ADDITIONAL FINDINGS INCLUDE; SWITCH TWO HAD A CUT AND AIR WATER CYLINDER HAD NO COLOR. SUCTION CYLINDER ALSO HAD NO COLOR. CABLE UNIT AND PLUG UNIT HAD CORROSION DUE TO WATER LEAKAGE. DUE TO BURN ON PLASTIC DISTAL END COVER, INSULATION RESISTANCE VALUE AT DISTAL END DID NOT MEET THE STANDARD VALUE. OBJECTIVE LENS AND LIGHT GUIDE LENS HAD A CRACK. CONNECTING TUBE HAD A WRINKLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE CORRECTION OF THE INITIAL MDR AND 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. IT HAS BEEN OVER FIVE (5) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE PROBABLE CAUSE OF THE MALFUNCTION COULD NOT BE IDENTIFIED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: IFU STATES THE DETECTION METHOD IN GIF/CF/PCF-190 SERIES OPERATION MANUAL CHAPTER 3 PREPARATION AND INSPECTION . IFU STATES THE PREVENTATIVE MEASURES IN GIF/CF/PCF-190 SERIES 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 THAT THE SCREEN WAS BLACK WITH RED STARS ON THE VIDEO SCOPE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND; THE AIR/WATER CYLINDER AND TUBE HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT HARM. 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
    2245892 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H190 04953170305290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown