BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 13261775 · Received January 14, 2022

    Report

    Report Number
    8010047-2022-01487
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Report Date
    December 8, 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
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION FOUND THE NOZZLE IS FOUND MISSING, THE CUSTOMER REPORTED ISSUE COULD BE CONFIRMED. DUE TO MISSING NOZZLE, AMOUNT OF WATER CONTACT DOES NOT MEET THE STANDARD VALUE. DUE TO MISSING NOZZLE, WATER REMOVAL ABILITY DOES NOT MEET THE STANDARD VALUE. FURTHERMORE, FORCEPS ELEVATOR FOUND WITH FOREIGN MATERIALS. IN ADDITION, THE FOLLOWING FINDINGS WERE NOTED ON THE DEVICE. DUE TO A CUT ON UNIVERSAL CORD, WATER TIGHTNESS IS LOST. ADHESIVE ON A-RUBBER IS DETACHED. A-RUBBER IS DIRTY. UNIVERSAL CORD HAS A CUT. US CONNECTOR OF CONTACT PINS IS CORROSION. MOUTHPIECE IS LOOSE. DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN UP,DOWN,LEFT DIRECTION DOES NOT MEET THE STANDARD VALUE. DUE TO WEAR OF ANGLE WIRE, THE PLAY OF U/D, R/L KNOB IS OUT OF THE STANDARD VALUE. DUE TO MISSING NOZZLE, WATER REMOVAL ABILITY DOES NOT MEET THE STANDARD VALUE. DUE TO CLOGGING OF AW-TUBE, NO WATER/AIR IS FED. DUE TO DEFORMATION OF DISTAL END, BALLOON SUCTION VOLUME DOES NOT MEET THE STANDARD VALUE. NO ELECTRICAL CONTINUITY DUE TO DAMAGE ON DISTAL END. ACOUSTIC LENS IS DAMAGED. 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, CUSTOMER FOLLOW-UP AND CORRECTION. CHECKED "OTHER" TO ADD THE COUNTRY INDIA. CUSTOMER CONFIRMED THE ISSUE WAS FOUND DURING PREPARATION FOR USE. 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 EVENT LIKELY OCCURRED BECAUSE THE FOREIGN MATERIAL THAT ADHERED TO THE FORCEPS ELEVATOR DURING THE PROCEDURE COULD NOT BE REMOVED BY REPROCESSING. THE SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 16-DEC-2021.

    Description of Event or Problem · 0

    AS REPORTED, CHANNEL BLOCK AND NOZZLE MISSING. THE ISSUE FOUND DURING AN UNKNOWN EVENT. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. DEVICE INSPECTION FOUND FORCEPS ELEVATOR HAS FOREIGN MATERIAL. THIS REPORT IS BEING SUBMITTED FOR ELEVATOR HAS FOREIGN MATERIAL.

    Description of Event or Problem · 0

    THE CUSTOMER CONFIRMED THE EVENT WAS FOUND AT PREPARATION FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017875 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown