BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 10618568 · Received October 2, 2020

    Report

    Report Number
    8010047-2020-07123
    Event Type
    Malfunction
    Date Received
    October 2, 2020
    Report Date
    January 14, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND TO CORRECT INFORMATION PROVIDED ON THE INITIAL REPORT. THE OLYMPUS REPAIR CENTER FOUND THE CIRCUIT BOARD MANAGEMENT SYSTEM OF THE PROCESSOR WAS DEFECTIVE. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE EVENT OCCURRED DUE TO A FAILURE OF THE OPERATIONAL AMPLIFIER. THERE HAS SINCE BEEN A DESIGN CHANGE TO THE OPERATIONAL AMPLIFIER CIRCUIT BOARD.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WERE NO FURTHER DETAILS PROVIDED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS SERVICE OPERATION REPAIR CENTER WAS INFORMED BY THE FACILITY THAT IN UNSPECIFIED TIMING ENDOSCOPIC IMAGE WITH PINK STRIPES APPEARED ON THE MONITOR. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS SERVICE OPERATION REPAIR CENTER, NO ENDOSCOPIC IMAGE WAS DISPLAYED WHEN OLYMPUS 180, 165, 160, 145 SERIES ENDOSCOPES WERE CONNECTED TO THIS DEVICE. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1086353 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET OLYMPUS MEDICAL SYSTEMS CORP. CV-190

    Patients

    Seq Age Sex Outcome Treatment
    1