BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 12888891 · Received November 29, 2021

    Report

    Report Number
    8010047-2021-15226
    Event Type
    Malfunction
    Date Received
    November 29, 2021
    Report Date
    December 26, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS KOREA (OKR). OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. IN ADDITION, OMSC CONFIRMED THAT DR BOARD DESIGN CHANGE HAS BEEN MADE ON APRIL 16, 2018, REGARDING THE PHENOMENON, IMAGE NOISE WITH 180 AND 150 SCOPES AND THE SUBJECT DEVICE WAS MANUFACTURE ED BEFORE THE DESIGN CHANGE. BASED UPON THE INFORMATION FROM OKR, OMSC CONCLUDED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FAILURE OF THE PRINTED CIRCUIT BOARD (DR BOARD) OF THE SUBJECT DEVICE. HOWEVER, THE EXACT CAUSE OF THE PRINTED CIRCUIT BOARD FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS (B)(4). (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT IMAGE NOISE OCCURRED ON THE SUBJECT DEVICE WHEN CONNECTING WITH EVIS 180/150 SCOPES, WHICH MIGHT BE CAUSED BY THE BREAKAGE OF THE PRINTED CIRCUIT BOARD (DR BOARD), AND ALSO FOUND THAT THERE WAS NO ABNORMALITY ON THE SUBJECT DEVICE WHEN CONNECTING WITH EVIS 190/170 SCOPES. THE EXACT CAUSE HAS BEEN UNDER INVESTIGATION. THEREFORE, 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 · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE INSPECTION BEFORE THE USE, IT WAS FOUND THAT IMAGE ABNORMALITIES SUCH AS IMAGE DISTORTION OCCURRED ON THE SUBJECT DEVICE WHEN EVIS 150 SERIES VIDEO SCOPES WAS CONNECTED TO THE SUBJECT DEVICE, AND ALSO FOUND THAT THE IMAGE WAS NORMAL WHEN EVIS 170 SERIES VIDEO SCOPE WAS CONNECTED TO THE SUBJECT DEVICE. IN ADDITION, IT WAS FOUND THAT IMAGES WERE NORMAL WHEN USING ANOTHER SYSTEM WITH THE USED EVIS 150 SERIES VIDEO SCOPE. THE OCCURRENCE DATE OF THE EVENT IS UNKNOWN, AND THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1779407 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown