BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 12830238 · Received November 17, 2021

    Report

    Report Number
    8010047-2021-14692
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 5, 2021
    Report Date
    December 1, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    ODG
    UDI-DI
    04953170356339
    PMA / PMN Number
    K093395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. INSPECTION FOUND THE REPORTED CUSTOMER ISSUE WAS CONFIRMED. TWO LEAKS WERE FOUND , BIOPSY CHANNEL HAS TEAR MARKS, LEAKING AND LEAK FROM INLET AT THE BODY CONTROL UNIT (BCU) ELEVATOR CHANNEL WAS NOTED. FURTHER INSPECTION FOUND FORCEPS COVER GLUE PEELING, PROBE UNIT PINK RUBBER FLABBY. FURTHERMORE, ADDITIONAL FINDINGS BELOW: A-RUBBER GLUE-CRACK, OB LENS -CHIPPED-NOT AFFECTING IMAGE, LG LENS -GLUE PEELING, FORCEPS PASSAGE -BX CHANNEL INTERNAL TER MARKS, LEAKING. UM IMAGE -4 CONSECUTIVE BROKEN ELEMENTS, ELEVATOR CH W/F -LEAK OUTER SIDE OF THE INLET, CONTROL BODY -CUSTOMER LABEL-NOT AFFECTING FUNCTION. CONTROL BODY -FLUID INVASION. CONTROL BODY -S-COVER PLATE LOOSE. CONTROL KNOB -PLAY. 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 CAUSE OF THE FORCEPS COVER GLUE PEELING LIKELY OCCURRED DUE TO AN EXTERNAL FORCE APPLIED TO THE PART. INVESTIGATION CONFIRMED THAT THERE WAS NO ADHESIVE IN THE POSITION WHERE ADHESIVE SHOULD HAVE BEEN APPLIED. THE SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. THE FOLLOWING INFORMATION IS STATED IN THE INSTRUCTIONS FOR USE: "INSPECTION OF THE ENDOSCOPE 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.

    Description of Event or Problem · 0

    AS REPORTED DURING MANUAL CLEANING AND REPROCESSING, SMALL LEAK AT DISTAL TIP WAS OBSERVED. THERE IS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO USER INJURY REPORTED. DEVICE RETURN EVALUATION FOUND PEELING ON FORCEPS COVER GLUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1726974 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown