BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III VIDEO SYSTEM CENTER

    MDR report key: 15770729 · Received November 10, 2022

    Report

    Report Number
    3002808148-2022-04011
    Event Type
    Malfunction
    Date Received
    November 10, 2022
    Report Date
    January 6, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD
    Product Code
    FET
    UDI-DI
    04953170298622
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED, AND AN INITIAL EVALUATION WAS CONDUCTED BY OLYMPUS; HOWEVER, INVESTIGATION IS ONGOING. DURING THE DEVICE EVALUATION, THE USER¿S REPORT WAS CONFIRMED, THE VIDEO CONNECTOR WAS FOUND DEFECTIVE. ADDITIONALLY, THE IMAGE WAS FOUND FLICKERING INTERMITTENTLY. THE SPECIAL SCOPE FEATURES WERE NOT FUNCTIONING PROPERLY. THE TOP COVER AND FRONT PANEL BOTH HAD POOR APPEARANCES. IF ADDITIONAL INFORMATION BECOMES AVAILABLE FOLLOWING THE DEVICE EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER¿S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE OBSERVED FLICKERING VIDEO ISSUE. THE DHR CONFIRMED THAT THE SUBJECT DEVICE WAS SHIPPED IN ACCORDANCE WITH THE SPECIFICATIONS. A DEFINITIVE ROOT CAUSE FOR THE FLICKERING IMAGE ISSUE WAS NOT ESTABLISHED, HOWEVER, IT IS PROBABLE THE ISSUE WAS THE RESULT OF A DAMAGED CIRCUIT BOARD (AP BOARD), WHICH HAS SCOPE CONTROL FUNCTION, VIDEO DATA TRANSMISSION FUNCTION, AND VIDEO SIGNAL-PROCESSING FUNCTION. ADDITIONALLY, THE RECEPTACLE WAS FOUND TO BE DAMAGED. A DEFINITIVE ROOT CAUSE FOR THE OBSERVED DAMAGE WAS NOT DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT HIS OLYMPUS EVIS EXERA III VIDEO SYSTEM CENTER HAD A COMPROMISED CONNECTION. ACCORDING TO THE INITIAL REPORTER, THERE WERE BENT PINS FOUND IN THE INPUT COMPARTMENT OF THE CONNECTOR. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT. DURING THE DEVICE EVALUATION, IT WAS CONFIRMED THAT THE IMAGE WAS FLICKERING INTERMITTENTLY. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE LACK OF A CONSISTENT IMAGE PRODUCIBLE DURING THE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060088 EVIS EXERA III VIDEO SYSTEM CENTER VIDEO SYSTEM CENTER FET SHIRAKAWA OLYMPUS CO., LTD CV-190 04953170298622

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown