BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 12481111 · Received September 16, 2021

    Report

    Report Number
    8010047-2021-11831
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 23, 2021
    Report Date
    November 11, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. BASED UPON THE INFORMATION FROM OAZ, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FAILURE OF THE PRINTED-CIRCUIT BOARD BECAUSE THE SUBJECT DEVICE WAS A PRODUCT BEFORE THE COUNTERMEASURES WERE TAKEN BY DESIGN CHANGE OF THE PRINTED-CIRCUIT BOARD IN THE PATIENT BOARD.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS DUPLICATED DUE TO THE FAILURE OF THE PRINTED-CIRCUIT BOARD. 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 A MAINTENANCE, IT WAS FOUND THAT THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED WHEN TJF-Q180V WAS CONNECTED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380853 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown