BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 13367633 · Received January 27, 2022

    Report

    Report Number
    8010047-2022-02080
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Report Date
    March 2, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INSPECTION FOUND LEAK AT THE DISTAL END WAS NOT CONFIRMED AS NO LEAK WAS OBSERVED HOWEVER, THE HOLD RING WAS FOUND CRACKED AND THE INSIDE LENS WERE FOUND DIRTY. IN ADDITION, THE FOLLOWING FINDINGS DURING INSPECTION WERE NOTED BELOW: OB LENS SCRATCHED AND CHIPPED. LG (LIGHT GUIDE) LENS SCRATCHED. A-RUBBER GLUE CHIPPED. THERE ARE WHITE DOTS ON THE IMAGE. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTION: G2 ("KOREA" CORRECTED TO "SOUTH KOREA"). 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. THE SUGGESTED EVENT OF "INSIDE OF LG [LIGHT GUIDE] LENS WAS DIRTY" WAS PRESUMED TO HAVE BEEN DUE TO: I) LG LENS WAS BROKEN BY PHYSICAL STRESS ON THE DISTAL END. II) DIRT ENTERED THE DEVICE FROM THE BREAKING POINT; OR, COMPONENTS INSIDE THE LG LENS WERE CORRODED BY INFLUENCE OF MOISTURE WHICH ENTERED DEVICE FROM THE BREAKING POINT. THEN, CORROSION PRODUCT WAS DETECTED AS DIRT. THE SUGGESTED EVENT OF "HOLD RING WAS CRACKED" WAS PRESUMED TO HAVE BEEN DUE TO: A) USER APPLIED EXCESSIVE FORCE TO THE DISTAL END OF DEVICE WHEN ATTACHING / DETACHING THE DISTAL COVER. B) USER HANDLED DEVICE IN A MANNER THAT SHOCKED THE DISTAL END (SUCH AS HITTING). THE SUGGESTED EVENTS WERE DETERMINED AS PREVENTABLE; THE FOLLOWING INSTRUCTIONS FOR USE (IFU) STATE THE FOLLOWING REGARDING DETECTION: ¿DO NOT STRIKE, BEND, HIT, PULL, TWIST, OR DROP THE ENDOSCOPE¿S DISTAL END, INSERTION TUBE, BENDING SECTION, CONTROL SECTION, UNIVERSAL CORD, OR ENDOSCOPE CONNECTOR OF THE ENDOSCOPE WITH EXCESSIVE FORCE. THE ENDOSCOPE MAY BE DAMAGED AND COULD CAUSE PATIENT INJURY, BURNS, BLEEDING AND/OR PERFORATIONS. IT COULD ALSO CAUSE PARTS OF THE ENDOSCOPE TO FALL OFF INSIDE THE PATIENT.¿ OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    AS REPORTED , DISTAL LEAK WAS OBSERVED . THE ISSUE FOUND AT PREPARATION FOR USE. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT. DEVICE EVALUATION FOUND THE DEVICE HOLD RING WAS FOUND CRACKED. THE INSIDE OF LG (LIGHT GUIDE) LENS WERE FOUND DIRTY. THIS REPORT IS BEING SUBMITTED FOR INSIDE LENS OF LIGHT GUIDE DIRTY AND CRACKED HOLD RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102086 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown