BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 13261376 · Received January 14, 2022

    Report

    Report Number
    8010047-2022-01474
    Event Type
    Malfunction
    Date Received
    January 14, 2022
    Date of Event
    December 7, 2021
    Report Date
    December 8, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    UDI-DI
    04953170339776
    PMA / PMN Number
    K100584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 19-DEC-2021.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AND EVALUATED AND OBSERVED WITH DEFORMATION OF THE EL-CONNECTOR CAUSING LOST OF WATER TIGHTNESS. SCRATCHES ON THE S-CONNECTOR NOTED. THE CUSTOMER ISSUE COULD BE CONFIRMED. FURTHERMORE, THE NOZZLE WAS FOUND WITH FOREIGN OBJECTS AND OBSERVED WITH DENT. DUE TO NOZZLE CLOGGING, AMOUNT OF WATER CONTACT DOES NOT MEET THE STANDARD VALUE. DUE TO CLOGGING OF NOZZLE, WATER REMOVAL ABILITY DOES NOT MEET THE STANDARD VALUE. IN ADDITION, THE FOLLOWING FINDINGS WERE OBSERVED IN THE DEVICE: LG LENS IS DIRTY. C-COVER HAS A DENT. C-COVER IS DIRTY. ADHESIVE ON A-RUBBER HAS WEAR. CONNECTING TUBE HAS COATING PEELING. CONNECTING TUBE HAS A SCRATCH. CONNECTING TUBE HAS DISCOLORATION. CONNECTING TUBE HAS A WRINKLE. IG PROTECTOR HAS A CUT. GRIP HAS A SCRATCH; CONTROL UNIT HAS A SCRATCH. CONTROL UNIT IS DIRTY. SWITCH BOX HAS A SCRATCH. S-CYLINDER IS DIRTY. S-CYLINDER IS SHAVED. R/L KNOB IS DIRTY, U/D KNOB IS DIRTY. S-COVER HAS A DENT. UNIVERSAL CORD HAS A SCRATCH. EL (ELEVATOR)-CONNECTOR HAS CORROSION LG (LIGHT GUIDE)-COVER GLASS HAS A DENT S-CONNECTOR IS DIRTY AW-CYLINDER IS DIRTY DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN UP&DOWN DIRECTIONS DO NOT MEET THE STANDARD VALUE DUE TO WEAR OF ANGLE WIRE, THE PLAY OF U/D&R/L KNOBS ARE OUT OF THE STANDARD VALUE. 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 AND TO CORRECT INFORMATION PROVIDED ON THE INITIAL REPORT. 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 LEGAL MANUFACTURER'S INVESTIGATION, IT IS LIKELY ACCESSORIES OF THE SUBJECT DEVICE (WATER CONTAINER, AIR/WATER VALVE, CLEANING TOOLS OR THE LIKE) BECAME BROKEN AND GOTTEN INTO THE AIR/WATER CHANNEL. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING RELATED VERBIAGE WHICH MAY HELP PREVENT THE PHENOMENON: ¿INSPECTION OF THE ENDOSCOPE: INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION SECTION, INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, SCRATCHES, PEELING OF COATING, HOLES, SAGGING, TRANSFORMATION, BENDS, ADHESION OF FOREIGN BODIES, MISSING PARTS, PROTRUDING OBJECTS, OR OTHER IRREGULARITIES. INSPECT THE FOLLOWING EQUIPMENT AS DESCRIBED IN THEIR RESPECTIVE INSTRUCTION MANUALS.¿ ¿TO PREVENT CLOGGING OF THE AIR/WATER NOZZLE OF THE ENDOSCOPE, FLUSH WATER INTO THE AIR CHANNEL OF THE ENDOSCOPE, USING THE AW CHANNEL CLEANING ADAPTER (MH-948) AFTER EACH PATIENT PROCEDURE. TROUBLESHOOTING - THE ACCESSORIES ARE CONSUMABLES. OLYMPUS DOES NOT REPAIR ACCESSORY PARTS. IF AN ACCESSORY PART BECOMES DAMAGED, CONTACT OLYMPUS TO PURCHASE A REPLACEMENT.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED BASED ON CUSTOMER RESPONSE AND UPDATES.

    Description of Event or Problem · 0

    AS REPORTED, LEAK WAS FOUND ON THE CONNECTOR. THE ISSUE FOUND DURING AN UNKNOWN EVENT. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED. DEVICE INSPECTION FOUND NOZZLE HAS FOREIGN OBJECTS. THIS REPORT IS BEING SUBMITTED FOR NOZZLE FOUND WITH FOREIGN OBJECTS.

    Description of Event or Problem · 0

    UPDATE ON EVENT REPORTED BASED ON CUSTOMER RESPONSE AND UPDATES: COMMUNICATION WITH THE CUSTOMER, THE FOLLOWING INFORMATION CONVEYED: THE ISSUE HAPPENED DURING THE REPROCESSING STEP AND NO PROCEDURE AND NO PATIENT IS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692769 EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H180 04953170339776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown