BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K CAMERA HEAD

    MDR report key: 17765355 · Received September 18, 2023

    Report

    Report Number
    3002808148-2023-09954
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 28, 2023
    Report Date
    February 12, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. 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, THE ROOT CAUSE OF THE EVENT WAS UNABLE TO BE IDENTIFIED. IT IS LIKELY THAT THE OPTICAL TRANSMISSION LINE ON THE 4KCH SIDE WITHIN OTV IS MALFUNCTIONING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE 4K CAMERA HEAD HAD A COMMUNICATION ERROR (E226) WHILE BEING USED IN CONJUNCTION WITH A VISERA ELITE III VIDEO SYSTEM CENTER. THE ISSUE WAS FOUND DURING AN UNSPECIFIED PROCEDURE THAT WAS THEN COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS REPORT IS BEING SUBMITTED FOR THE CAMERA HEAD INVOLVED IN THE EVENT. THE VISERA ELITE III VIDEO SYSTEM CENTER IS BEING REPORTED IN THE MDR WITH PATIENT IDENTIFIER 181580.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332414 4K CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. CH-S700-XZ-EA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown