BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 15504915 · Received September 29, 2022

    Report

    Report Number
    3002808148-2022-02561
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Report Date
    November 7, 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
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    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. IT HAS BEEN OVER 4 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS CONFIRMED THE B30 ERROR MESSAGE DISPLAYED DUE TO A BROKEN CABLE CONNECTOR WHICH FAILED COMMUNICATION. HOWEVER, THE SPECIFIC ROOT CAUSE OF THE CABLE CONNECTOR FAILURE COULD NOT BE DETERMINED AT THIS TIME. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED TO OLYMPUS AND EVALUATED. THE REPORTED PROBLEM WAS CONFIRMED AND THE CAUSE ISOLATED TO A CABLE CONNECTOR FAILURE. 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.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED TO OLYMPUS THAT AN ERROR "B30" OCCURRED UPON CONNECTION OF THE OLYMPUS, MODEL CH-S190-XZ-E, HD AUTOCLAVABLE CAMERA HEAD TO A PROCESSOR AND START UP OF THE PROCESSOR. THE PROCEDURE WAS DELAYED 15 MINUTES DUE TO THE PROBLEM; THE PATIENT WAS UNDER ANESTHESIA DURING THE DELAY. THE INTENDED PROCEDURE, A LAPAROSCOPIC HYSTERECTOMY, WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE EVENT, REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766887 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