BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 18458211 · Received January 5, 2024

    Report

    Report Number
    3002808148-2024-30033
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Date of Event
    December 6, 2023
    Report Date
    February 7, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170228834
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION OF NO IMAGE WAS CONFIRMED DUE TO LOOSENED CAMERA UNIT. ADDITIONALLY, OTHER EVALUATION FINDINGS INCLUDE THE FOLLOWING: THERE WAS CORROSION ON COUPLER MOUNT, DUE TO DETERIORATION OF CABLE UNIT, WATER TIGHTNESS WAS LOST, DUE TO POOR WATER-TIGHTNESS OF COUPLER MOUNT, WATER TIGHTNESS WAS LOST, AND THERE WAS A CUT ON CABLE UNIT. DEVICE HISTORY RECORD (DHR) REVIEW: A DHR WAS REVIEWED AND NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE WERE FOUND. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS CAUSE TRACED TO COMPONENT FAILURE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Additional Manufacturer Narrative · 0

    G1: MANUFACTURING CONTACT FACILITY NAME: SHIRAKAWA OLYMPUS CO., LTD. THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION BASED ON LEGAL MANUFACTURER'S FINAL INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE HIGH DEFINITION AUTOCLAVABLE CAMERA HEAD HAD NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601402 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S7PROH-HD-12E 04953170228834

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown