BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 13935265 · Received March 29, 2022

    Report

    Report Number
    8010047-2022-05191
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Report Date
    May 25, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDS
    PMA / PMN Number
    K011151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RECEIVED AND EVALUATED. DEVICE INSPECTION AND EVALUATION, SERVICE REPAIR NOTED THE FOLLOWING FINDINGS: FOREIGN MATERIAL IS COMING OUT FROM TIP DUE TO BLOCKAGE OF BIOPSY CHANNEL. ADDITIONALLY, INSPECTION FOUND LIQUID LEAKS DUE TO CRUMPLED PART OF CONNECTING TUBE. THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. FURTHERMORE, THE FOLLOWING FINDINGS ON THE DEVICE WERE NOTED BELOW: INSULATION RESISTANCE IS OUT OF STANDARDS DUE TO PERFORATION OF CONNECTING TUBE. ANGULATION IN THE UP DIRECTION IS OUT OF STANDARDS DUE TO WORN OF ANGLE-WIRE. THE GAP OF U/D KNOB IS OUT OF STANDARDS DUE TO WORN OF ANGLE-WIRE. WATER QUANTITY IS OUT OF STANDARDS DUE TO DEFORMATION OF NOZZLE. WATER CLEANING FUNCTION IS OUT OF STANDARDS DUE TO DEFORMATION OF NOZZLE. SCREEN IS PARTLY DARK DUE TO SCRATCH OF CCD LENS. THE CONDITION OF LG-BUNDLE IS NOT GOOD. LG (LIGHT GUIDE) LENS IS BROKEN. THERE IS GAP AT THE ADHESIVE PART OF AR. THERE IS CREASE AT THE CONNECTING TUBE. S-COVER POLLUTED. BASED ON EVALUATION FINDINGS, THE CUSTOMER REPORTED FAILURE OF LEAKS WERE CONFIRMED. LEAKS WERE OBSERVED DUE TO CRUMPLED PART OF THE CONNECTING TUBE. 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. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THE SUGGESTED PHENOMENON WAS PRESUMED TO HAVE BEEN DUE TO THE FOLLOWING: ·REPROCESSING METHOD CONDUCTED BY THE USER WAS DIFFERENT FROM METHOD RECOMMENDED IN THE INSTRUCTIONS FOR USE (IFU). ·STAFF OF THE USER FACILITY WAS INSUFFICIENTLY TRAINED ON DEVICE HANDLING AND REPROCESSING IN ACCORDANCE WITH IFU. REPROCESSING MANUAL: 1.4 PRECAUTIONS WARNS FOR INSUFFICIENTLY REPROCESSING AS FOLLOWS: "¿ AN INSUFFICIENTLY REPROCESSED ENDOSCOPE AND/OR ACCESSORY MAY POSE AN INFECTION CONTROL RISK TO THE PATIENTS AND/OR OPERATORS WHO TOUCH THEM.". REPROCESSING MANUAL: PRECLEANING THE ENDOSCOPE AND ACCESSORIES STATES ON IMMEDIATE PRECLEANING AFTER PROCEDURE IN ORDER TO PREVENT ADHERENT OF DIRT: "IF THE ENDOSCOPE AND ACCESSORIES USED IN THE PATIENT PROCEDURE ARE NOT IMMEDIATELY CLEANED AFTER EACH PATIENT PROCEDURE, RESIDUAL ORGANIC DEBRIS WILL BEGIN TO DRY AND SOLIDIFY, HINDERING EFFECTIVE REMOVAL AND REPROCESSING EFFICACY. PRECLEAN THE ENDOSCOPE AND THE ACCESSORIES AT THE BEDSIDE IN THE PATIENT PROCEDURE ROOM IMMEDIATELY AFTER EACH PATIENT PROCEDURE.". MANUALLY CLEANING THE ENDOSCOPE AND ACCESSORIES STATES ON DETAILS OF METHODS OF BRUSHING AND CLEANING FOR EACH CHANNEL. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED WITH AN ISSUE OF LIQUID LEAKS AT THE INSERTION PART. THE ISSUE FOUND DURING PREPARATION FOR USE. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED. DEVICE EVALUATION FOUND FOREIGN MATERIAL COMING OUT FROM TIP DUE TO BLOCKAGE OF BIOPSY CHANNEL. THIS REPORT IS BEING SUBMITTED FOR (INSUFFICIENT CLEANING) FOREIGN MATERIAL FOUND COMING OUT FROM THE TIP DUE TO BLOCKAGE OF BIOPSY CHANNEL FOUND DURING DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890823 EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS OLYMPUS MEDICAL SYSTEMS CORP. GIF-H260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown