BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 12065087 · Received June 25, 2021

    Report

    Report Number
    8010047-2021-07973
    Event Type
    Malfunction
    Date Received
    June 25, 2021
    Report Date
    June 25, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO ANY OF OLYMPUS LOCATIONS. HOWEVER, THE FIELD SERVICE ENGINEER CHECKED THE SUBJECT DEVICE AT THE USER FACILITY AND FOUND THAT THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED WHILE THE EVIS 160/145 SERIES VIDEOSCOPE WAS CONNECTED AND THERE WAS NO FAILURE OF THE IMAGE WHILE THE EVIS 185/190 SERIES VIDEOSCOPE WAS CONNECTED. 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 THE FIELD SERVICE ENGINEER, OMSC SURMISED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FAILURE OF THE OPERATIONAL AMPLIFIER, BECAUSE THE SUBJECT DEVICE WAS THE PRODUCT PRIOR TO THE DESIGN IMPROVEMENT OF THE OPERATIONAL AMPLIFIER CIRCUIT ON THE PRINTED-CIRCUIT BOARD.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT BEFORE AN UNSPECIFIED PROCEDURE, IT WAS FOUND THAT THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED WHILE THE EVIS 180/160 SERIES VIDEOSCOPE WAS CONNECTED. THERE WAS NO FAILURE OF THE IMAGE WHILE THE EVIS 185/190 SERIES VIDEOSCOPE WAS CONNECTED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967173 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1