BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD CAMERA HEAD

    MDR report key: 20333422 · Received September 30, 2024

    Report

    Report Number
    3002808148-2024-36721
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 11, 2024
    Report Date
    December 4, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    PMA / PMN Number
    K102059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E2/E3: NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. . THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE FOLLOWING REPORTABLE MALFUNCTIONS WERE IDENTIFIED DURING THE DEVICE EVALUATION: CABLE UNIT DEPRESSED, WATER TIGHTNESS LOSS DUE TO A GAB ON CABLE UNIT. BASED ON THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE COULD NOT BE IDENTIFIED. THE CAUSE IS NOT ESTABLISHED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION FOR USE THE CAMERA HEAD HAD COLORED LINES AT THE EDGE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2608051 HD CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. CH-S190-08-LB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown