BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 15086522 · Received July 22, 2022

    Report

    Report Number
    3002808148-2022-00226
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Report Date
    September 13, 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
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY OLYMPUS. DURING THE EVALUATION, AN ERROR "B30" OCCURRED DUE TO CONTACT FAILURE OF THE VIDEO CONNECTOR. 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 (DHR) FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE NOISY IMAGE/ENDOSCOPE COMMUNICATION ERROR (B30). THE DHR CONFIRMED THAT THE SUBJECT DEVICE WAS SHIPPED IN ACCORDANCE WITH THE SPECIFICATIONS. A DEFINITIVE ROOT CAUSE FOR THIS ISSUE WAS NOT ESTABLISHED. HOWEVER, IT IS PROBABLE THAT THE ISSUE OCCURRED BECAUSE OF A CONTACT FAILURE WITH THE VIDEO CONNECTOR. 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 IMAGE WAS NOISY BUT THE SUBJECT COULD BE RECOGNIZED. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, A "B30" SCOPE COMMUNICATION ERROR OCCURRED. THIS REPORT IS SUBMITTED DUE TO THE FINDING OF B30 ERROR, IDENTIFIED DURING THE DEVICE EVALUATION. AS THE PROBLEM OCCURRED DURING IN-HOUSE SERVICE OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571011 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