BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA II VIDEO SYSTEM CENTER

    MDR report key: 16969545 · Received May 19, 2023

    Report

    Report Number
    3002808148-2023-05083
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 21, 2023
    Report Date
    July 14, 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
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    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 11 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, A DEFINITIVE ROOT CAUSE OF THE WORN-OUT VIDEO CONNECTOR PINS COULD NOT BE IDENTIFIED. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: [IMPORTANT INFORMATION ¿ PLEASE READ BEFORE USE]. DO NOT APPLY EXCESSIVE FORCE TO THIS VIDEO SYSTEM CENTER AND/OR OTHER INSTRUMENTS CONNECTED. OTHERWISE, DAMAGE AND/OR MALFUNCTION CAN OCCUR. [CHAPTER 8 INSTALLATION AND CONNECTION]. NEVER APPLY EXCESSIVE FORCE TO CONNECTORS. THIS COULD DAMAGE THE CONNECTORS. 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 IMAGE WAS BAD DUE TO WORN OUT VIDEO CONNECTOR PINS. BAD CONNECTOR PIN RESULTED IN POOR CONNECTION. THE DEVICE EVALUATION FOUND THAT THE WORN-OUT VIDEO CONNECTOR PINS WERE CAUSING A POOR CONNECTION WITH THE VIDEO CABLES AND A BAD IMAGE AS THE RESULT. THE INVESTIGATION IS ONGOING AND FOLLOW-UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II VIDEO SYSTEM CENTER HAD A BAD IMAGE. 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
    1076178 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