BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 16413783 · Received February 21, 2023

    Report

    Report Number
    9610595-2023-02899
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    January 26, 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
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE PRODUCT CODE FOR THE SUBJECT DEVICE FROM FDF TO FDS. SEE SECTION D2.

    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 WIRE STUCK WAS INSUFFICIENT REPROCESSING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS RETURNED, AND AN EVALUATION COMPLETED FOR IT. THE USER¿S COMPLAINT WAS CONFIRMED. UPON INSPECTION AND TESTING, IT WAS OBSERVED THAT THERE IS A WIRE STUCK IN THE BIOPSY CHANNEL CLOGGING IT. THE WIRE COULD NOT BE REMOVED BY PROPER REPROCESSING. DUE TO THE CLOGGING, NO BRUSH OR FORCEPS COULD BE PASSED THROUGH THE CHANNEL. THE SUCTION CHANNEL WAS ALSO CLOGGED. OTHER OBSERVATIONS FOR THE DEVICE: ADHESIVE OF DISTAL END RUBBER COATING (A-RUBBER) HAD CHIPS AND SWITCH (SW) SW1 HAD A CUT. EVALUATION IS ONGOING. SUPPLEMENTAL REPORT(S) WILL BE SUBMITTED WHEN ANY RELEVANT NEW INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED FOR THIS EVENT BY THE CUSTOMER, DURING PREPARATION FOR USE A WIRE WAS STUCK IN THE BIOPSY CHANNEL. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228255 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE FLEXIBLE VIDEO GASTRODUODENOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276
    158192 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE FLEXIBLE VIDEO GASTRODUODENOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown