BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 3CMOS AUTOCLAVABLE CAMERA HEAD

    MDR report key: 12877933 · Received November 26, 2021

    Report

    Report Number
    8010047-2021-15116
    Event Type
    Malfunction
    Date Received
    November 26, 2021
    Date of Event
    October 28, 2021
    Report Date
    February 8, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    OWN
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) COULD NOT IDENTIFY THE ROOT CAUSES OF THE REPORTED PHENOMENA. [CONSIDERATION] THE REPORTED PHENOMENA, E226 IS AN ERROR OCCURS WHEN COMMUNICATION FAILS BETWEEN THE CAMERA HEAD (THE SUBJECT DEVICE) AND THE VIDEO PROCESSOR. ACCORDING TO THE INSPECTION REPORT OF OLYMPUS AUSTRALIA, IT WAS REPORTED THAT THE CAMERA CABLE WAS REPLACED DURING REPAIR. THEREFORE, IT WAS PRESUMED THAT THE REPORTED PHENOMENA WERE OCCURRED DUE TO A COMMUNICATION FAILURE BY THE CAMERA CABLE FAILURE. THEN THE ERROR E226 MAY HAVE OCCURRED, AND THE IMAGE MAY HAVE BEEN NO LONGER DISPLAYED. THE INVESTIGATION RESULTS WERE AS FOLLOWS; -THERE WAS NO REPAIR HISTORY FOR THE SUBJECT DEVICE. -IT WAS REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. -IT WAS CONFIRMED THAT IT WAS REPLACED THE CAMERA CABLE BY OLYMPUS AUSTRALIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THE SUBJECT DEVICE WAS INSPECTED AT OLYMPUS (B)(4). IT WAS DUPLICATED THE REPORTED PHENOMENON WHICH THE IMAGE OF THE SUBJECT DEVICE WAS LOST. IN ADDITION THE ERROR E226 WHICH INDICATES THERE IS THE COMMUNICATION PROBLEM BETWEEN THE SUBJECT DEVICE AND THE VIDEO PROCESSOR WAS DISPLAYED. 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 · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE BIOMEDICAL ENGINEER OF THE USER FACILITY THAT THE IMAGE OF THE SUBJECT DEVICE WAS NOT DISPLAYED DURING THE PREPARATION FOR USE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1776330 HD 3CMOS AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD OWN OLYMPUS MEDICAL SYSTEMS CORP. CH-S200-XZ-EA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown