BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 11073996 · Received December 27, 2020

    Report

    Report Number
    8010047-2020-11025
    Event Type
    Malfunction
    Date Received
    December 27, 2020
    Date of Event
    December 2, 2020
    Report Date
    February 16, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170339967
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, BUT WAS RETURNED TO OLYMPUS AUSTRALIA (OAZ). OAZ INSPECTED THE DEVICE AND THE REPORTED PHENOMENON WAS NOT DUPLICATED. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM OAZ THERE WAS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FOLLOWING OCCURRENCE MECHANISM. - THE MOVEMENT OF THE FORCEPS ELEVATOR WAS TEMPORARILY HINDERED DUE TO FOREIGN OBJECT ADHERING TO THE AREA AROUND THE FORCEPS ELEVATOR.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE INSPECTION BY THE BIOMEDICAL ENGINEER, THE FORCEPS ELEVATOR COULD NOT MOVE DOWN AT ALL. OLYMPUS (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON COULD NOT DUPLICATED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1538878 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V 04953170339967

    Patients

    Seq Age Sex Outcome Treatment
    1