BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODENOVIDEOSCOPE

    MDR report key: 14781251 · Received June 22, 2022

    Report

    Report Number
    8010047-2022-10602
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Report Date
    May 10, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDT
    UDI-DI
    04953170229459
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER¿S ALLEGATION WAS CONFIRMED. THE EVALUATION UNCOVERED THE OBJECTIVE LENS HAD A SCRATCH, THE BENDING SECTION COVER GLUE HAD DISCOLORATION AND ADHESIVE WAS DETACHED, THE CONNECTING TUBE HAD A COATING PEELING, SCRATCH AND WRINKLE AND SUCTION-CYLINDER WAS SHAVED. ADDITIONALLY, THE SUCTION CONNECTOR HAD A SCRATCH, SUCTION COVER UNIT HAD A SCRATCH, RIGHT/ LEFT KNOB WAS DIRTY, DUE TO WEAR OF ANGLE WIRE, THE PLAY OF UP/DOWN / RIGHT/LEFT KNOB AND DIRECTION WAS OUT OF THE STANDARD VALUE, PLASTIC DISTAL END COVER WAS DIRTY AND LENS GUIDE LENS HAD A SCRATCH. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S 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 FOREIGN MATERIAL WAS NOT IDENTIFIED. NO DETERMINATION OF WHAT THE MATERIAL WAS, NOR HOW IT ENTERED THE DEVICE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE LEGAL MANUFACTURER¿S CONTACT INFORMATION AND FACILITY REGISTRATION NUMBER. THE FACILITY REGISTRATION NUMBER IS (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY RETURNED AN ASSET EVIS EXERA III VIDEO SYSTEM CENTER TO OLYMPUS TO THE SERVICE CENTER. THE USER FACILITY DID NOT REPORT A MALFUNCTION WITH THE DEVICE. UPON INSPECTION AND TESTING OF THE RETURNED UNIT, FORCEPS ELEVATOR HAD FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT 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
    277176 DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT AIZU OLYMPUS CO., LTD. TJF-150 04953170229459

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown