BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 15105834 · Received July 26, 2022

    Report

    Report Number
    3002808148-2022-00321
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Report Date
    August 31, 2022
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170310799
    PMA / PMN Number
    K102059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY OLYMPUS. THE EVALUATION FOUND NO WAS IMAGE WAS PRESENT DUE TO A CABLE FAILURE. ADDITIONALLY, IT WAS NOTED THAT THE COUPLER WAS STIFF DUE TO CORROSION. THE INVESTIGATION IS ONGOING AND THE DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    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 FAILED CABLE UNIT COULD NOT BE IDENTIFIED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    A USER FACILITY RETURNED THE OLYMPUS, MODEL CH-S190-XZ-E, HD AUTOCLAVABLE CAMERA HEAD TO OLYMPUS FOR REPAIR DUE TO A REPORT THAT THE VIDEO WAS "DARK." THE PROBLEM, AS REPORTED TO OLYMPUS, WAS IDENTIFIED DURING PREPARATION FOR USE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS DETERMINED NO IMAGE WAS PRESENT DUE TO CABLE FAILURE. THIS REPORT IS SUBMITTED DUE TO THE FINDING OF NO IMAGE, IDENTIFIED DURING THE DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759106 HD AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. CH-S190-XZ-E 04953170310799

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown