BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD CAMERA HEAD

    MDR report key: 18458913 · Received January 5, 2024

    Report

    Report Number
    3002808148-2024-30036
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Report Date
    February 8, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170228834
    PMA / PMN Number
    K083155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE INFORMATION SUPPLIED BY THE MANUFACTURER. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION OF EXPOSED WIRES WAS CONFIRMED DUE TO DETERIORATED 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. INSTRUCTIONS FOR USE (IFU): ¿IF THE CAMERA HEAD IS VISIBLY DAMAGED, DOES NOT FUNCTION AS EXPECTED OR IS FOUND TO HAVE OTHER IRREGULARITIES DURING THE INSPECTION DESCRIBED IN CHAPTER 3, ¿PREPARATION AND INSPECTION¿, DO NOT USE THE CAMERA HEAD. CONTACT OLYMPUS¿. THE MOST PROBABLE CAUSE OF THE COMPLAINT IS DUE TO COMPONENT FAILURE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907265 HD CAMERA HEAD CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S7PROH-HD-L08E 04953170228834

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown