BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 12745639 · Received November 3, 2021

    Report

    Report Number
    8010047-2021-14011
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    September 15, 2021
    Report Date
    April 27, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE OLYMPUS SCOPE WAS SENT TO AN INDEPENDENT LABORATORY FOR CULTURE TESTING AND THE CUSTOMER¿S ALLEGATION COULD NOT BE CONFIRMED. THE DISTAL END OF THE DEVICE WAS SWABBED AND TESTED ALONG WITH THE WASHINGS FROM THE BIOPSY/SUCTION AND AIR/WATER CHANNELS. THE OBTAINED RESULTS ARE IN CONFORMANCE WITH THE REQUIREMENTS. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND THE DEVICE EVALUATION. THE DEVICE WAS EVALUATED WHERE NO ABNORMALITIES WERE FOUND THOUGH THERE WERE SEVERAL TECHNICAL DEFECTS SUCH AS LENS CRACKED, POROUS/BROKEN GLUE AROUND LENSES, CONNECTING TUBE BUCKLED, NAME PLATE MISSING, IMPACT POINT AT THE PLUG UNIT. THESE DEFECTS WERE NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT AND ARE LIKELY DUE TO WEAR AND TEAR DAMAGE FROM USE OVER AN EXTENDED PERIOD OF TIME. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 3 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATION BETWEEN THE EVENT AND THE DEVICE COULD NOT BE CONFIRMED. THE METHOD OF REPROCESSING AT THE USER FACILITY WAS UNKNOWN, THOUGH SEVERAL ATTEMPTS WERE MADE. NO ABNORMALITY OR LEAKAGE FROM THE CHANNELS WAS CONFIRMED ON THE SUBJECT DEVICE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE AIR-WATER CHANNEL ON THE EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR ONE (1) COLONY FORMING UNIT (CFU) OF A BACILLUS SPECIES WHEN PERFORMING A MICROBIOLOGICAL EXAMINATION OF THE ENDOSCOPE USING SWABS AND WASHINGS. THE TEST WAS THEN REPEATED AFTER ANOTHER CYCLE OF CLEANING, DISINFECTION AND STERILIZATION BUT THE SCOPE STILL TESTED POSITIVE. THE CUSTOMER WITHDREW THE SCOPE FROM SERVICE AND REQUESTED A CLEANING OF THE AFFECTED CHANNEL. THE SCOPE WAS WASHED USING OLYMPUS ENDOTHERMO DISINFECTORS (ETD 3 AND ETD 4). ACCORDING TO THE CUSTOMER, THE TESTS FOR THE OTHER SCOPES CLEANED IN ETD 3 AND ETD 4 WERE NEGATIVE. THE SCOPE WAS PRE-CLEANED USING A 1-2% SOLUTION OF SEKUSEPT MULTIENZYME. 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
    1643081 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H185

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown