BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAMERA HEAD

    MDR report key: 23605146 · Received November 20, 2025

    Report

    Report Number
    3002808148-2025-22921
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 24, 2025
    Report Date
    January 22, 2026
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170142215
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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 FINAL INVESTIGATION. UPDATED FIELDS: D9, H2, H3, H6, H11. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTED FAILURE WAS CONFIRMED. IN ADDITION, THE MOISTURE INSIDE THE CHARGED COUPLED DEVICE COVER GLASS WAS IDENTIFIED DURING THE DEVICE EVALUATION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION, THE MOST PROBABLE ROOT CAUSE OF THE MALFUNCTION TOO BLURRY TO USE WAS MOISTURE INSIDE THE CHARGED COUPLED DEVICE COVER GLASS AND THE MOST PROBABLE ROOT CAUSE OF THE MALFUNCTION MOISTURE INSIDE THE CHARGED COUPLED DEVICE COVER GLASS WAS MULTIPLE PINHOLES IN THE VIDEO 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 CAMERA HEAD PRODUCED AN IMAGE THAT WAS TOO BLURRY. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79681 CAMERA HEAD CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S7H-1D-L08E 04953170142215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown