BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II VIDEO SYSTEM CENTER

    MDR report key: 16729633 · Received April 13, 2023

    Report

    Report Number
    3002808148-2023-03671
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Report Date
    May 18, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FAJ
    UDI-DI
    04953170215513
    PMA / PMN Number
    K133538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 14 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE DEFECTIVE/FAULTY POWER SUPPLY UNIT, SEVERAL MISSING/LOOSE SCREWS AND NUTS, A MISSING FAN UNIT, DEFECTIVE/FAULTY CIRCUIT BOARD, DEFECTIVE/FAULTY PRINTED CIRCUIT BOARD, LOOSE VIDEO CONNECTOR SOCKET, LOOSE CORE BRACKET, AND MISSING COVERS COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION FOUND UNABLE TO POWER ON THE DEVICE DUE TO DEFECTIVE POWER SUPPLY UNIT. SEVERAL SCREWS AND NUTS WERE LOOSE AND MISSING. TOP COVER AND REAR PANEL WERE CORRODED. THE FAN UNIT WAS MISSING. THE FRONT PANEL WAS FROZEN AND NOT FUNCTIONING DUE TO DEFECTIVE PRINTED CIRCUIT BOARD. THE FRONT PANEL WAS CRACKED. NO IMAGE WAS DISPLAYED DUE TO DEFECTIVE CIRCUIT BOARD. THE VIDEO CONNECTOR SOCKET WAS LOOSE AND CORE BRACKET AND COVERS WERE MISSING. SPACERS WERE BROKEN. THE LOWER SHIELD WAS MISSING. IMAGE DISPLAYED HAD HORIZONTAL LINES DUE TO FAULTY PRINTED CIRCUIT BOARD. FLEX CABLE CONNECTOR WAS BROKEN. THE CHASSIS WAS CORRODED AND UNABLE TO SECURE SCREWS. UNABLE TO DETECT PRINTED CIRCUIT BOARD CARD. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THERE WAS NO POWER AND NO IMAGE AFTER TURNING ON THE EVIS EXERA II VIDEO SYSTEM CENTER. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991518 EVIS EXERA II VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FAJ SHIRAKAWA OLYMPUS CO., LTD. CV-180 04953170215513

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown