BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K CAMERA HEAD

    MDR report key: 10624227 · Received October 3, 2020

    Report

    Report Number
    8010047-2020-07176
    Event Type
    Malfunction
    Date Received
    October 3, 2020
    Date of Event
    September 7, 2020
    Report Date
    November 1, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K172817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, THEREFORE OMSC COULD NOT INVESTIGATE THE SUBJECT DEVICE. 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 INFORMATION FROM OLYMPUS AUSTRALIA, THERE WAS THE POSSIBILITY THAT THIS PHENOMENON WAS ATTRIBUTED TO THE BREAKAGE OF THE CAMERA CABLE OR THE CAMERA HEAD DUE TO THE USER HANDLING. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT WAS NOT RETURNED TO OMSC FOR EVALUATION THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INSPECTION OF THE SUBJECT DEVICE AT OLYMPUS (B)(4) (OAZ) FOR MAINTENANCE, THE CAMERA HEAD COMMUNICATION ERROR E224 WAS DISPLAYED. OAZ ALSO FOUND THAT THERE WAS AN ABNORMALITY ON THE EXTERIOR OF THE ELECTRICAL CONTACTS OF THE VIDEO CONNECTOR, SUCH AS DISCOLORATION. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088875 4K CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S400-XZ-EB

    Patients

    Seq Age Sex Outcome Treatment
    1