BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 15872019 · Received November 28, 2022

    Report

    Report Number
    3002808148-2022-04634
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    October 30, 2022
    Report Date
    January 17, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD
    Product Code
    ODG
    UDI-DI
    04953170356346
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER¿S INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE LEGAL MANUFACTURER, THE OTHER DEVICE ISSUES IDENTIFIED BY SERVICE HAVE NO POTENTIAL TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTIONS WERE TO RECUR. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ALL CHANNELS OF THE ENDOSCOPE, INCLUDING THE ELEVATOR WIRE CHANNEL AND BALLOON CHANNEL, MUST BE CLEANED AND HIGH-LEVEL DISINFECTED OR STERILIZED DURING EVERY REPROCESSING CYCLE, EVEN IF THE CHANNELS WERE NOT USED DURING THE PREVIOUS PATIENT PROCEDURE. OTHERWISE, INSUFFICIENT CLEANING AND DISINFECTION OR STERILIZATION OF THE ENDOSCOPE MAY POSE AN INFECTION CONTROL RISK TO THE PATIENT AND/OR OPERATORS PERFORMING THE NEXT PROCEDURE WITH THE ENDOSCOPE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO INFORM THE UPDATES/CORRECTION FROM THE INITIAL MDR REPORT. MANUFACTURER NAME AND ESTABLISHMENT NAME AND ADDRESS IS BEING UPDATE AS BELOW: AIZU OLYMPUS CO., LTD. FROM THE INITIAL REPORT WAS UPDATED AND CHANGED TO SHIRAKAWA OLYMPUS CO., LTD AS THE MANUFACTURER. THE CORRECT MANUFACTURER IS SHIRAKAWA OLYMPUS CO., LTD AND NOT AIZU OLYMPUS CO., LTD.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. DEVICE EVALUATION FOUND CLOGGED STENT INSIDE THE WORKING CHANNEL AND CLOGGING OF THE CH-TUBE. DUE TO CLOGGING, SERVICE REPAIR NOTED FOREIGN OBJECTS CAME OUT OF THE DISTAL END. STENT WAS PULLED OUT DURING THE INSPECTION. THE CUSTOMER REPORTED ISSUE COULD BE CONFIRMED. IN ADDITION, SERVICE REPAIR NOTED ACOUSTIC LENS (PINK PROBE UNIT) HAS A CHIP, DAMAGE HAS NOT REACHED THE ACOUSTIC LENS GLUE. FURTHERMORE, THE FOLLOWING DEFECTS WERE IDENTIFIED DURING DEVICE INSPECTION: DUE TO DEFORMATION OF EL-CONNECTOR GUIDE PIN, WATER TIGHTNESS NOTED LOST. DUE TO WEAR, SWITCH 1 (SW1) FOUND NOT WORKING (NON FUNCTIONAL). DUE TO DAMAGE ON SWITCH 1 (SW1), AN IMAGE FOUND FROZEN AND RECORDED ON ITS OWN. DUE TO DAMAGE ON ULTRASONIC PROBE, DISPLAYED ULTRASOUND IMAGE FOUND DEFECTIVE WITH MISSING ELEMENTS. DUE TO WEAR OF ANGLE WIRE, THE PLAY OF UP/DOWN (U/D) KNOB FOUND OUT OF THE STANDARD VALUE. DUE TO WEAR OF ANGLE WIRE, THE PLAY OF RIGHT/LEFT (R/L) KNOB FOUND OUT OF THE STANDARD VALUE. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED WITH AN ISSUE OF "METAL STENT STUCK IN THE WORKING CHANNEL. WORKING CHANNEL IS BLOCKED". THE ISSUE FOUND DURING AN UNKNOWN EVENT. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. DEVICE EVALUATION, SERVICE REPAIR FOUND CLOGGING OF THE CHANNEL-TUBE ( CH-TUBE), FOREIGN OBJECTS NOTED TO BE COMING OUT FROM THE DISTAL END. ADDITIONALLY, IT WAS DETERMINED THE PROBE UNIT HAS A CHIP, HAS DAMAGE (MISSING PIECE / CHIP / PARTS FELL OFF ON). THIS REPORT IS BEING SUBMITTED FOR FOREIGN OBJECT FOUND EXITING FROM THE CH-TUBE (HANDLING, INSUFFICIENT CLEANING ISSUE) AND DAMAGED ON PROBE UNIT DUE TO PHYSICAL STRESS BY DROPPING AND OR KNOCKING THE AFFECTED PART TO A HARD SURFACE/OBJECT AND APPLYING A CHEMICAL STRESS DURING CLEANING /SANITIZATION PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2663805 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG SHIRAKAWA OLYMPUS CO., LTD GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown