BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD CAMERA HEAD

    MDR report key: 18893022 · Received March 13, 2024

    Report

    Report Number
    3002808148-2024-31379
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Report Date
    May 9, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170336669
    PMA / PMN Number
    K102059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: OLYMPUS AMERICA INC. *LOANER DEPT* ATTN: LOANER DEPT. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE REPORTER. TO DATE, DEVICE HAS NOT YET BEEN RETURNED. 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 NOT CONFIRMED. THE DEVICE EVALUATION FOUND THE DEVICE DOES DID NOT HAVE A PROBLEM. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO DEVIATIONS, THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE CAMERA HEAD HAD AN E226 / E228 SCOPE COMMUNICATION ERROR AND AN IMAGE THAT DID NOT APPEAR. THE ISSUE OCCURRED DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE CAMERA HEAD HAD AN E226/E228 SCOPE COMMUNICATION ERROR. AND AN IMAGE, THAT DID NOT APPEAR. THE ISSUE OCCURRED, DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150734 HD CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. CH-S190-08-LB 04953170336669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown