BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 16378363 · Received February 15, 2023

    Report

    Report Number
    9610595-2023-02521
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    January 24, 2023
    Report Date
    June 27, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED WITH A REQUEST FOR DAMAGE INSPECTION. LEAK WAS DETECTED IN LIGHT GUIDE TUBE. THE DEVICE EXHIBITED LOW ANGULATION. THE PLAY OF THE ANGLE KNOB WAS OUT OF THE NORMAL STATE DUE TO THE ELONGATION OF THE ANGLE WIRE. THE DISTAL END COVER HAD DENTS/SCRATCHES. THE ADHESIVE OF THE OBJECTIVE LENS AND LIGHT GUIDE LENS WAS WORN OUT. THE ADHESIVE OF THE BENDING SECTION COVER WAS CRACKED. THE INSERTION TUBE HAD A DENT AND HAD MINOR SCRATCHES. THE INVESTIGATION IS ONGOING AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL WILL BE SUBMITTED ON COMPLETION OF INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S 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 ROOT CAUSE OF THE CLIP WAS INCORRECT HANDLING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE PRODUCT CODE FOR THE SUBJECT DEVICE FROM FDF TO FDS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, A CLIP WAS LODGED IN THE GASTROINTESTINAL VIDEOSCOPE. THE ISSUE WAS FOUND DURING A PROCEDURE. THE CLIP WAS DISLODGED. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158190 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE FLEXIBLE VIDEO GASTRODUODENOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276
    927846 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE FLEXIBLE VIDEO GASTRODUODENOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown