BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 18387189 · Received December 22, 2023

    Report

    Report Number
    3002808148-2023-20012
    Event Type
    Malfunction
    Date Received
    December 22, 2023
    Date of Event
    November 24, 2023
    Report Date
    February 9, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170228834
    PMA / PMN Number
    K955404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    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

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION OF DISPLAYED IMAGE WAS CONFIRMED. DEVICE EVALUATION FOUND THAT THE REPORTED ISSUE WAS DUE TO A FAULTY CABLE. ADDITIONALLY, OTHER EVALUATION FINDINGS INCLUDE THE FOLLOWING: SCOPE DID NOT ROTATE SMOOTHLY. 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): ¿SHOULD ANY IRREGULARITY BE OBSERVED, DO NOT USE THE CAMERA HEAD; CONTACT OLYMPUS.¿ THE MOST PROBABLE CAUSE OF THE COMPLAINT IS CAUSE TRACED 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 AUTOCLAVABLE CAMERA HEAD IMAGE QUALITY WAS POOR, AND IMAGE DISPLACED. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION RESULTS. IN ADDITION, A CORRECTION TO THIS REPORT WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288444 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