BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K CAMERA HEAD

    MDR report key: 11758672 · Received May 1, 2021

    Report

    Report Number
    8010047-2021-05724
    Event Type
    Malfunction
    Date Received
    May 1, 2021
    Report Date
    May 27, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K172817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), IT COULD NOT BE INVESTIGATED. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER BASED ON THE REPORT OF THE SERVICE DEPARTMENT OF OLYMPUS EUROPE SE & CO. KG (OEKG) AND A THING WHICH THERE WAS NO VISIBLE DAMAGE TO THE CAMERA CABLE BUT IT SEEMED THE CAMERA CABLE WAS BROKEN INTERNALLY, OMSC SURMISED THERE WAS THE POSSIBILITY THOSE PHENOMENA WERE ATTRIBUTED TO THE CAMERA CABLE BREAK OF THE SUBJECT DEVICE BY BENDING AND TORSION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OMSC BUT WAS RETURNED TO THE SERVICE DEPARTMENT OF OLYMPUS EUROPE (B)(4) FOR EVALUATION. THE SERVICE DEPARTMENT OF OLYMPUS EUROPE (B)(4) CHECKED THE SUBJECT DEVICE AND CONFIRMED THAT THERE WAS NO COMMUNICATION BETWEEN THE SUBJECT DEVICE AND THE CAMERA CONTROL UNIT, AND NO IMAGE OF THE SUBJECT DEVICE WAS. BUT IT COULD NOT DUPLICATE THE ERROR, E222/224. IT WAS FOUND THE REPLACEMENT NEED OF THE CAMERA CABLE OF THE SUBJECT DEVICE. THERE WAS NO VISIBLE DAMAGE OF THE CAMERA CABLE, BUT IT SEEMED THAT THE INTERNAL WIRES OF THE CAMERA CABLE WERE INTERRUPTED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT THE ERROR, E222/224 WHICH INDICATED THAT THERE WAS THE COMMUNICATION FAILURE BETWEEN THE SUBJECT DEVICE AND THE CAMERA CONTROL UNIT WERE DISPLAYED AND THE IMAGE OF THE SUBJECT DEVICE WAS NOT DISPLAYED AT THE PREPARATION FOR USE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654760 4K CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S400-XZ-EB

    Patients

    Seq Age Sex Outcome Treatment
    1