BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 18901785 · Received March 14, 2024

    Report

    Report Number
    3002808148-2024-02404
    Event Type
    Malfunction
    Date Received
    March 14, 2024
    Date of Event
    February 29, 2024
    Report Date
    April 9, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    ODG
    UDI-DI
    04953170356339
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO MFR(S) 05102 (1/3), 05145(2/3) BASED ON THE OBSERVATION SUMMARY REPORT FROM AN ENDOSCOPY SUPPORT SPECIALIST (ESS), THERE WERE SOME REPROCESSING DEVIATIONS OBSERVED DURING THE ON-SITE VISIT, AND THEY ARE AS FOLLOWS: 1) BEDSIDE PRE-CLEANING STEPS NOT FOLLOWED FOR GIF SCOPE, EUS OR COLON SCOPE. MAJ-1888 OLYMPUS BRUSH BEING USED ON EUS SCOPES. UMBILICAL END OF SCOPE NOT IMMERSED DURING LEAKAGE TESTING. 2) NOTED STAFF CARRYING SCOPE CONTAINER OVER THEIR HEAD WITH ONE HAND OUT OF PROCEDURE ROOM. 3) NOTED STAFF CAUSING DAMAGE TO UMBILICAL END OF SCOPE DURING TRANSITION FROM UPPER ENDOSCOPY TO COLONOSCOPY WHILE MOVING BOOM FROM ONE SIDE OF ROOM TO OTHER SIDE. THE ESS PROVIDED OLYMPUS BEDSIDE PRE-CLEANING POSTERS FOR GASTROINTESTINAL SCOPES AND EUS SCOPES. PROVIDED REPROCESSING POSTERS FOR GI, TJF-Q190V, EUS AND 180 EBUS SCOPE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO CORRECT THE FOLLOWING FIELDS: B5: DESCRIBE EVENT OR PROBLEM. D10: CONCOMITANT MEDICAL PRODUCTS. H10: PROVIDE NARRATIVE/DATA: THE PREVIOUSLY LISTED RELATED MFR(S) WERE INCORRECTLY ADDED. IN ADDITION TO CORRECTING THE FOLLOWING: BASED ON THE OBSERVATION SUMMARY REPORT FROM AN ENDOSCOPY SUPPORT SPECIALIST (ESS), THERE WERE SOME REPROCESSING DEVIATIONS OBSERVED DURING THE ON-SITE VISIT, AND THEY ARE AS FOLLOWS: THE USER FACILITY STAFF WAS FOUND THE BEDSIDE PRE-CLEANING STEPS NOT FOLLOWED, THEY DID NOT USE THE AIR/WATER CHANNEL CLEANING ADAPTER OR THE WASHING TUBE FOR FLUSHING OF THE ELEVATOR WIRE, A STAFF MEMBER CARRYING A STORAGE CONTAINER ABOVE THEIR HEAD WITH ONE HAND AND DURING LEAKAGE TESTING IT WAS NOTED THE STAFF NOT COMPLETELY IMMERSING THE SCOPE IN THE WATER. THE ESS PROVIDED A REPROCESSING IN-SERVICE OR REPROCESSING TRAINING TO THE USER FACILITY STAFF. THE ESS PROVIDED THE USER FACILITY STAFF REPROCESSING TRAINING MATERIALS FOR THEIR REFERENCE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF 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 SEVEN (7) YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE LEGAL MANUFACTURE WAS ABLE TO CONFIRM THAT THE CUSTOMER'S REPROCESSING STEPS WERE DEVIATED FROM THE INSTRUCTIONS FOR USE. BASED ON THE RESULTS OF THE INVESTIGATION, ROOT CAUSE CANNOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT DURING AN ONSITE VISIT, THE USER FACILITY STAFF DID NOT PERFORM ANY PRE-CLEANING STEPS ON GIF SCOPE IN TRANSITION TO COLONOSCOPY DURING DOUBLE PROCEDURE, THEY DID NOT USE THE AIR/WATER CHANNEL CLEANING ADAPTER OR THE WASHING TUBE FOR FLUSHING OF THE ELEVATOR WIRE, A STAFF MEMBER CARRYING A STORAGE CONTAINER ABOVE THEIR HEAD WITH ONE HAND AND THE STAFF USED A MAJ-1888 CLEANING BRUSH ON THE GF-UTC180 EUS SCOPE. NO PATIENT INFECTIONS OR INJURIES

    Description of Event or Problem · 0

    OLYMPUS WAS INFORMED THAT DURING AN ONSITE VISIT, THE USER FACILITY STAFF WAS FOUND THE BEDSIDE PRE-CLEANING STEPS NOT FOLLOWED, THEY DID NOT USE THE AIR/WATER CHANNEL CLEANING ADAPTER OR THE WASHING TUBE FOR FLUSHING OF THE ELEVATOR WIRE, A STAFF MEMBER CARRYING A STORAGE CONTAINER ABOVE THEIR HEAD WITH ONE HAND. NOTED STAFF USING THE MAJ-1888 CLEANING BRUSH ON THE GF-UTC180 EUS SCOPE, AND DURING LEAKAGE TESTING IT WAS NOTED THE STAFF NOT COMPLETELY IMMERSING THE SCOPE IN THE WATER. NO PATIENT INFECTIONS OR INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2448176 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD. GF-UCT180 04953170356339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CF-HQ190L| GIF-UCT-180| MAJ-1888