BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 18433336 · Received January 3, 2024

    Report

    Report Number
    3002808148-2024-30007
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Report Date
    January 3, 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
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G1: MANUFACTURER CONTACT FACILITY NAME: SHIRAKAWA OLYMPUS CO., LTD. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. THE DEVICE EVALUATION FOUND THE CABLE IS CUT. A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, THE MOST PROBABLE CAUSE OF THE COMPLAINT IS TRACED TO COMPONENT FAILURE, WHICH IS EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THIS ISSUE IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU): "NEVER CLEAN, DISINFECT, STERILIZE, OR STORE THIS CAMERA HEAD TOGETHER WITH SHARP-TIPPED INSTRUMENTS (TWEEZERS, FORCEPS, KNIVES, ETC.). DOING SO COULD SCRATCH OR TEAR HOLES IN THE CAMERA CABLE, WHICH COULD ALLOW WATER TO PENETRATE AND DAMAGE ELECTRICAL CIRCUITS INSIDE THE CAMERA HEAD." OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE HIGH DEFINITION AUTOCLAVABLE CAMERA HEAD HAS A "CUT ON THE CORD". THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1574267 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S7PROH-HD-12E 04953170228834

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown