BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 13936692 · Received March 29, 2022

    Report

    Report Number
    8010047-2022-05208
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    February 2, 2022
    Report Date
    September 1, 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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FULL NAME OF CUSTOMER ESTABLISHMENT IS (B)(6). THE SUBJECT DEVICE WAS EVALUATED. DEVICE EVALUATION FOUND FOREIGN MATERIAL ON THE FORCEPS LEVER AND ACOUSTIC LENS HAS A SCRATCH WHICH REACHES TO THE GLUE-LAYER. ADDITIONALLY, THE FOLLOWING FINDINGS WERE NOTED ON THE DEVICE DURING INSPECTION. DEVICE ANGULATION INSPECTION CONFIRMED THE CUSTOMER REPORTED ISSUE OF ANGULATION FREE PLAY. THE ANGLE WIRES WERE STRETCHED. DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN DOWN DIRECTION DOES NOT MEET THE STANDARD VALUE DUE TO WEAR OF ANGLE WIRE, BENDING ANGLE IN LEFT DIRECTION DOES NOT MEET THE STANDARD VALUE DUE TO WEAR OF ANGLE WIRE, THE PLAY OF U/D KNOB IS OUT OF THE STANDARD VALUE DUE TO WEAR OF ANGLE WIRE, THE PLAY OF R/L KNOB IS OUT OF THE STANDARD VALUE THE CUSTOMER REPORTED ISSUE OF ANGULATION FREE PLAY WAS CONFIRMED. FURTHERMORE, THE FOLLOWING FINDINGS WERE NOTED ON THE DEVICE UPON INSPECTION DUE TO CLOGGING OF NOZZLE, WATER REMOVAL ABILITY DOES NOT MEET THE STANDARD VALUE ADHESIVE ON A-RUBBER HAS A DISCOLORED AREA A-RUBBER HAS WEAR, COATING PEELING ON UNIVERSAL CORD, SCRATCH ON OBJECTIVE LENS, AND LIGHT GUIDE FOUND DIRTY. -DUE TO DAMAGE ON CH-TUBE, WATER TIGHTNESS IS LOST -DUE TO DAMAGE ON ULTRASONIC CABLE, THE NUMBER OF MISSING ELEMENT EXCEEDS THE STANDARD VALUE -DUE TO DAMAGE ON ACOUSTIC LENS, INSULATION RESISTANCE VALUE DOES NOT MEET 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 CORRECTION TO G3. E2 E3- INFORMATION HAS BEEN REQUESTED BUT UNKNOWN AT THIS TIME. CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 01-MAR-2022 A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE MET ALL SPECIFICATIONS AT THE TIME OF SHIPMENT. IT HAS BEEN OVER 9 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE CAUSE OF THE SCRATCHED ACOUSTIC LENS LIKELY OCCURRED FROM EXTERNAL FORCE APPLIED TO THE PART. THE CAUSE OF THE FOREIGN MATERIAL LIKELY OCCURRED FROM INCORRECT REPROCESSING. THE SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. THE FOLLOWING INFORMATION IS STATED IN THE INSTRUCTIONS FOR USE: "3. INSPECT THE EXTERNAL SURFACE OF THE ENTIRE INSERTION SECTION INCLUDING THE BENDING SECTION AND THE DISTAL END FOR DENTS, BULGES, SWELLING, SCRATCHES, HOLES, SAGGING, TRANSFORMATION, BENDS, ADHESION OF FOREIGN BODIES, MISSING PARTS, PROTRUDING OBJECTS, OR OTHER IRREGULARITIES." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER. REFERENCE B3, B5, E1, E2, E3, G2 AND H6 FOR UPDATES.

    Description of Event or Problem · 0

    CUSTOMER SENT A REPAIR REQUEST WITH AN ISSUE OF ANGULATION WORKS BUT ANGULATION CONTROL KNOB FEELS TOO LOOSE OR LIGHT .ANGULATION PLAY IN ALL DIRECTIONS. THE ISSUE FOUND DURING AN UNKNOWN EVENT. DEVICE EVALUATION FOUND FORCEPS ELEVATOR HAS FOREIGN MATERIAL AND THE ACOUSTIC LENS HAS A SCRATCH WHICH REACHES TO THE GLUE-LAYER. THIS REPORT IS BEING SUBMITTED FOR FORCEPS ELEVATOR HAS FOREIGN MATERIAL AND THE ACOUSTIC LENS HAS A SCRATCH WHICH REACHES TO THE GLUE-LAYER WHICH WAS OBSERVED DURING DEVICE EVALUATION.

    Description of Event or Problem · 0

    CUSTOMER CONFIRMED THE EVENT OCCURRED DURING REPROCESSING OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32313 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356346

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown