BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II DUODENOVIDEOSCOPE

    MDR report key: 11683254 · Received April 18, 2021

    Report

    Report Number
    8010047-2021-05055
    Event Type
    Malfunction
    Date Received
    April 18, 2021
    Date of Event
    March 24, 2021
    Report Date
    October 2, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    PMA / PMN Number
    K143153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUBJECT DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION BUT WAS RETURNED TO OLYMPUS AUSTRALIA AND NEW ZEALAND (OAZ). OMSC REVIEWED THE DEVICE HISTORY RECORD (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 AND PAST SIMILAR CASE, THERE WAS THE POSSIBILITY THAT THIS PHENOMENON WAS ATTRIBUTED TO TEMPORARY INHIBITION OF THE FORCEPS ELEVATOR MOVEMENT DUE THE ADHESION OF THE FOREIGN MATERIAL AROUND THE FORCEPS ELEVATOR.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS (B)(6) AND (B)(6) (OAZ). OAZ CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON COULD NOT BE DUPLICATED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING UNSPECIFIED TIMING, IT WAS FOUND THAT THE FORCEPS ELEVATOR REMAINED BEEN RAISED AND DID NOT MOVE DOWN AT ALL. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580707 EVIS EXERA II DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-Q180V

    Patients

    Seq Age Sex Outcome Treatment
    1