BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA DUODENOVIDEOSCOPE

    MDR report key: 16075939 · Received December 29, 2022

    Report

    Report Number
    9610595-2022-06321
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Report Date
    February 24, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED BY OLYMPUS. UPON INSPECTION OF THE DEVICE, IT WAS OBSERVED THAT THE ADHESIVE OF THE LIGHT GUIDE (LG) LENS WAS PEELED WITH A GAP PRESENT IN THE GLUED END OR DIRT ENTERED THE LENS THROUGH THE GAP. ADDITIONAL EVALUATION FINDINGS ARE AS FOLLOWS: 1.) K-WIRE COMPLETELY CUT OFF; 2.) DUE TO WEAR OF ANGLE WIRE, THE BENDING ANGLE IN THE UP DIRECTION DID NOT MEET SPECIFICATION; 3.) ADHESIVE ON THE BENDING SECTION COVER DETACHED AND CRACKED; 4.) DUE TO WEAR OF THE ANGLE WIRE, THE UP/DOWN KNOB PLAY WAS OUT OF SPECIFICATION; 5.) SCRATCH NOTED ON CONNECTING TUBE AND DISTAL END COVER; 6.) ADHESIVE AROUND LG LENS NOTED PEELED; 7.) SCOPE CONNECTOR SCRATCHED; 8.) PROTECTOR OF UNIVERSAL CORD ON SCOPE CONNECTOR NOTED SCRATCHED; 9.) PROTECTOR OF UNIVERSAL CORD ON CONTROL SECTION SIDE NOTED SCRATCHED; 10.) UNIVERSAL CORD NOTED SCRATCHED; 11.) SCRATCH ON BOOT NOTED; 12.) FORCEPS CHANNEL PORT NOTED SCRATCHED; 13.) SCRATCH ON GRIP; 14.) DISTAL END COVER, SCOPE CONNECTOR COVER, SWITCH BOX, FE KNOB, UP/DOWN KNOB, RIGHT/LEFT KNOB, FE LEVER, ALL NOTED SCRATCHED; 15. CONTROL UNIT DISCOLORED WITH SCRATCH. THE INVESTIGATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    REUSE SHOULD HAVE BEEN SELECTED ON THE INITIAL REPORT RATHER THAN UNKNOWN. 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 ROOT CAUSE OF THE EVENT WAS UNABLE TO BE IDENTIFIED; HOWEVER, THE EVENT MOST LIKELY OCCURRED DUE TO USE STRESS, EXTERNAL FACTORS, AND HANDLING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    A USER FACILITY RETURNED TO OLYMPUS THE OLYMPUS, MODEL TJF-260V, EVIS LUCERA DUODENOVIDEOSCOPE FOR REPAIR DUE TO THE REPORTED PROBLEM OF "BROKEN FORCEPS LIFTING WIRE." THERE WAS NO REPORTED HARM TO A PATIENT ASSOCIATED WITH THE PROBLEM. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE ADHESIVE OF THE LIGHT GUIDE (LG) LENS WAS PEELING; A GAP IN THE GLUED END WAS PRESENT OR DIRT ENTERED THE LENS THROUGH THE GAP. THIS MEDWATCH IS BEING SUBMITTED FOR THE REPORTABLE ISSUE OF THE PEELING OF THE LG LENS ADHESIVE AND GAP IN THE GLUED END, AS OBSERVED DURING DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2409705 EVIS LUCERA DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-260V

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown