BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HEAD

    MDR report key: 20227151 · Received September 16, 2024

    Report

    Report Number
    3002808148-2024-36454
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Report Date
    October 11, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170142246
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: FACILITY NAME: (B)(6) HOSPITAL E1: ADDRESS: 171-1 HOKAMA, SHIMAJIRIGUN YAESECHO, OKINAWA, 9010417. 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. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. 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: THERE IS WATER INGRESS IN THE MAIN UNIT IMAGING AND IN THE CAMERA CABLE. THERE IS CORROSION INSIDE THE OLEDOME, ON THE SCOPE MOUNT AND ON THE VIDEO CONNECTOR ELECTRICAL CONTACT POINT. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: THERE WAS A CRACK IN THE CAMERA CABLE, AND IT WAS UNABLE TO MAINTAIN AIRTIGHTNESS. IT IS PRESUMED THAT MOISTURE THAT HAD ENTERED THE INTERIOR CAUSED FLOODING OF THE MAIN UNIT AND CAMERA CABLE. 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 THE SUBJECT DEVICE HAD CRACKED CORD. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT DEVICE HAD CRACKED CORD. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441307 CAMERA HEAD CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S7H-1D-F08E 04953170142246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown