BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

    MDR report key: 12657852 · Received October 19, 2021

    Report

    Report Number
    8010047-2021-13347
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Report Date
    February 8, 2022
    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
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: G2 ("OTHER" CHECKED - FIELD POPULATED AS CANADA). 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, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. IT WAS OBSERVED FROM THE IMAGE PROVIDED THAT THERE WERE SCRATCHES AROUND THE INDICATED AREA. IT THEREFORE IS A POSSIBLE CAUSE THAT SOME KIND OF EXTERNAL FORCE WAS APPLIED TO THE RELEVANT PART. THE INSTRUCTIONS FOR USE DOCUMENTS THE FOLLOWING RELEVANT DATA REGARDING THE 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, 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 · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. AFTER TROUBLESHOOTING, FORCEPS WERE ABLE TO PASS IN BOTH THE FORCEPS AND BALLOON PASSAGE. MISSING, CRACKED OR PEELING GLUE WAS FOUND ON THE LIGHT GUIDE COVER, FORCEPS MECHANISM COVER/LID, PROBE SCREW, PROBE AND BENDING SHEATH COVER. THE PROBE WAS ALSO OBSERVED TO BE CUT. IN ADDITION, THE CEMENT ON THE LIGHT GUIDE LENS WAS PERFORATED, THERE WAS ONE BROKEN ELEMENT, THE BODY CONTROL UNIT HAD A LOOSE GUIDE PIPE, THE SIDE COVER WAS OPEN AND THE WATER MOUTHPIECE WAS LOOSE. THE CONTROL KNOB WAS SCRATCHED (METAL NOT EXPOSED), LOOSE AND EXPERIENCING PLAY. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO OLYMPUS, THE BIOPSY CHANNEL OF THE EXIS EXERA II ULTRASOUND GASTROVIDEOSCOPE WAS OBSERVED TO BE BLOCKED DURING REPROCESSING. DURING THE INSPECTION OF THE RETURNED DEVICE, THERE WAS MISSING GLUE ON THE LIGHT GUIDE COVER AND THE FORCEPS COVER AND THE PINK PROBE HAD A CUT AND HAD PEELING GLUE ON THE SIDE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1558772 EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE ULTRASOUND GASTROVIDEOSCOPE ODG OLYMPUS MEDICAL SYSTEMS CORP. GF-UCT180 04953170356339

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown