BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 11698888 · Received April 21, 2021

    Report

    Report Number
    8010047-2021-05184
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    April 7, 2021
    Report Date
    June 4, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS RETURNED TO THE SERVICE DEPARTMENT OF OLYMPUS. THE SERVICE DEPARTMENT OF OLYMPUS CHECKED THE SUBJECT DEVICE AND FOUND THAT THE VIDEO CONNECTOR HAD CRACKS. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. OMSC PRESUMED THAT A PARTIAL CONTACT FAILURE WITH THE PROCESSOR OCCURRED DUE TO THE CRACKED VIDEO CONNECTOR. THEREFORE THE SUBJECT DEVICE STOPPED DISPLAYING IMAGES WHEN THE CABLE WAS MOVED. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO THE SERVICE DEPARTMENT OF OLYMPUS. THE SERVICE DEPARTMENT OF OLYMPUS CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON WAS DUPLICATED. IT WAS ALSO FOUND THAT NO IMAGE WAS DISPLAYED AFTER PLUGGING IN, AND AFTERWARDS IT SHOWED DOTS AND LINES. THE FAULT WAS INTERMITTENT AND IMAGE WORKED NORMALLY WHEN CABLE WAS MANIPULATED. 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 THAT DURING THE PREPARATION FOR USE, THE SCREEN WAS BLACK AND NO IMAGE WAS DISPLAYED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO THE SERVICE DEPARTMENT OF OLYMPUS. THE SERVICE DEPARTMENT OF OLYMPUS CHECKED THE SUBJECT DEVICE AND FOUND THAT NO IMAGE WAS DISPLAYED AFTER PLUGGING IN, AND AFTERWARDS IT SHOWED DOTS AND LINES. THE FAULT WAS INTERMITTENT AND IMAGE WORKED NORMALLY WHEN CABLE WAS MANIPULATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597818 HD AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S190-XZ-E

    Patients

    Seq Age Sex Outcome Treatment
    1