BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 20077815 · Received August 27, 2024

    Report

    Report Number
    9610595-2024-17139
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 4, 2024
    Report Date
    October 8, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE DEVICE EVALUATION AND THE LEGAL MANUFACTURE¿S FINAL INVESTIGATION. CORRECTION B3 OF THE INITIAL REPORT. CORRECTION TO B5 OF THE INITIAL REPORT. PLEASE SEE B5 FOR FURTHER INFORMATION. CORRECTION TO H6 "MEDICAL DEVICE PROBLEM CODE" OF THE INITIAL REPORT, "2303 - MICROBIAL CONTAMINATION OF DEVICE" IS BEING CORRECTED TO "4048 - FAILURE TO CLEAN ADEQUATELY". THE DEVICE WAS RETURNED AND EVALUATED ON RELATED MFR 16384 WHERE NO ABNORMALITIES WERE FOUND THAT COULD HAVE LED TO THE REPORTED EVENT. 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, THERE WAS DIFFERENCE OF RECOGNITION ON DEVICE HANDLING BETWEEN THE USER AND RECOMMENDATION BY OLYMPUS. THE FOLLOWING IS INCLUDED IN THE DEVICE IFU: "AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. THIS REPORT IS RELATED TO THE FOLLOWING MFRS 16384 (1/8), 18132 (2/8), 17127 (3/8), 17108 (4/8), 17343 (5/8), 17173 (6/8), 17858 (8/8).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED HAVING USED THE SUBJECT DEVICE ON 8 PATIENTS WHILE AWAITING THE RESULTS FOR ROUTINE CULTURE TESTING. POSITIVE CULTURE TEST RESULTS WERE SUBSEQUENTLY RECEIVED. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1464156 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-H185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown