BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 14946926 · Received July 7, 2022

    Report

    Report Number
    8010047-2022-11504
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Report Date
    September 21, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170356346
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. DEVICE EVALUATION FOUND NO IMPROPER DEFLATION OF THE BALLOON WAS IDENTIFIED. DEVICE EVALUATION, SERVICE REPAIR NOTED : A FULL TECHNICAL EVALUATION WAS COMPLETED IN ACCORDANCE WITH THE OME (ORIGINAL EQUIPMENT MANUFACTURER) SPECIFICATION. WHEN INSPECTING THE BALLOON WATER SUPPLY, FIRSTLY, IT WAS CONFIRMED THAT THE VALVES (TEST VALVES) USED DURING THE TEST WERE IN A FULLY FUNCTIONAL STATE. THE BALLOON WAS ATTACHED TO THE BALLOON APPLICATOR MAJ-675, THEN TO THE DISTAL END GROOVE, AND NO AIR BUBBLES WERE MIXES INTO THE BALLOON. WHEN PUTTING WATER INTO THE BALLOON BY DEPRESSING THE AIR/WATER VALVE COMPLETELY, THE DISTAL END OF THE SCOPE WAS POINTED UPWARD AND THE RUBBER OF THE BALLOON INFLATED PROPERLY. NEXT, THE BALLOON WAS COMPLETELY DEFLATED WHILE DEPRESSING THE SUCTION VALVE. THE AIR/WATER SUPPLY VOLUME WAS INSPECTED FOR AN AIR AND WATER FLOW ISSUE, NEITHER AIR NOR WATER AT THE OUTPUT OF THIS ENDOSCOPE WAS OBSERVED DUE TO A CLOGGED NOZZLE, RATHER THAN A DEFLATION ISSUE OF THE BALLOON AS INITIALLY REPORTED BY THE CUSTOMER. TECHNICAL EVALUATION AND FURTHER INSPECTION HAVE NOT CONFIRMED THE CUSTOMER CLAIM CONCERNING AN IMPROPER DEFLATION OF THE BALLOON, BUT HAS IDENTIFIED SOLID AND TRANSLUCENT MATERIAL FOUND DURING THE INCOMING INSPECTION WHOSE ORIGIN COULD NOT BE IDENTIFIED AND REMOVED WAS CLOGGING THE NOZZLE, WITHOUT DETRIMENTAL DEFORMATION OF THE HOSE OF THE NOZZLE. CONCERNING THE GENERAL CONDITION OF THE SCOPE AND THE FURTHER INSPECTION FINDINGS, IT IS MOST LIKELY A RESULT OF WEAR DURING HANDLING AND REPROCESSING. BASED ON EVALUATION FINDINGS, SERVICE NOTED, IT IS ASSUME THAT THE CUSTOMER MAY HAVE ENCOUNTERED A DEFLATION PROBLEM OF THE BALLOON PERHAPS DUE TO DAMAGED VALVES THAT CAN SIGNIFICANTLY REDUCE THE VOLUME OF WATER ASPIRATED FROM THE BALLOON. THIS IS ONLY A HYPOTHESIS DUE NO ACCESSORIES WERE PROVIDED BY THE CUSTOMER. FURTHER INSPECTION FINDINGS, THE FOLLOWING WERE FOUND: AIR/WATER FLOW ISSUES FROM THE AIR/WATER FLOW SYSTEM (THE NOZZLE IS CLOGGED). A-RUBBER GLUE IS WORN OUT. ANGULATIONS ARE OUT OF SPECIFICATION. HF INTERNAL RESISTANCE VALUE IS OUT OF SPECIFICATION. THIS PRODUCT WAS PLACED IN SERVICE IN FEBRUARY 2020 AND HAS NEVER BEEN REPAIRED BEFORE. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON 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. BASED ON THE RESULTS OF THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE IDENTIFIED; HOWEVER, THE EVENT MOST LIKELY OCCURRED DUE FOREIGN MATTER BECOMING ACCUMULATED IN THE NOZZLE DURING THE PROCEDURE OR DURING REPROCESSING. IT IS LIKELY THAT THE FOREIGN MATTER IS EXTERNAL TO THE DEVICE. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: "REPROCESSING BEFORE THE FIRST USE/REPROCESSING AND STORAGE AFTER USE - AFTER USING THIS INSTRUMENT, REPROCESS AND STORE IT ACCORDING TO THE INSTRUCTIONS GIVEN IN THE ENDOSCOPE¿S COMPANION REPROCESSING MANUAL. IMPROPER AND/OR INCOMPLETE REPROCESSING OR STORAGE CAN PRESENT AN INFECTION CONTROL RISK, CAUSE EQUIPMENT DAMAGE, OR REDUCE PERFORMANCE." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BALLOON DOES NOT DEFLATE. THE ISSUE FOUND DURING DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. DEVICE EVALUATION FOUND DEVICE NOZZLE IS CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048311 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown