BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K CAMERA HEAD

    MDR report key: 12322905 · Received August 16, 2021

    Report

    Report Number
    8010047-2021-10267
    Event Type
    Malfunction
    Date Received
    August 16, 2021
    Date of Event
    July 19, 2021
    Report Date
    September 15, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUBJECT DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION BUT WAS RETURNED TO OLYMPUS AUSTRALIA AND NEW ZEALAND (OAZ). OMSC REVIEWED THE DEVICE HISTORY RECORD (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. BASED UPON THE INFORMATION FROM OAZ, OMSC CONSIDERED THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE FAILURE OF THE CABLE UNIT DUE TO THE EXCESSIVE FORCE BEING APPLIED ETC. BY THE USER HANDLING. OLYMPUS STATED THE APPROPRIATE HANDLING OF CH-S400-XZ-EB AND THE COUNTER MEASURES AGAINST ABNORMALITIES IN THE INSTRUCTION MANUAL OF CH-S400-XZ-EB.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OMSC FOR EVALUATION BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED PHENOMENON COULD NOT BE DUPLICATED. (B)(4) FOUND THE CAMERA HEAD COMMUNICATION ERROR E224 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 · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING UNSPECIFIED TIMING, IT WAS FOUND THAT THE SCOPE COMMUNICATION ERROR B30 WAS DISPLAYED.THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221800 4K CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S400-XZ-EB

    Patients

    Seq Age Sex Outcome Treatment
    1