BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 3CMOS AUTOCLAVABLE CAMERA HEAD

    MDR report key: 13041098 · Received December 19, 2021

    Report

    Report Number
    8010047-2021-16396
    Event Type
    Malfunction
    Date Received
    December 19, 2021
    Date of Event
    November 23, 2021
    Report Date
    February 15, 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. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. <E226 > A CABLE FAILURE HAD BEEN CONFIRMED DURING EVALUATION. THEREFORE, IT IS POSSIBLE THAT E226 OCCURRED BECAUSE THE VIDEO FUNCTION DID NOT OPERATE NORMALLY DUE TO A CABLE FAILURE. <NO IMAGE> CCD FAILURE HAD BEEN CONFIRMED DURING EVALUATION. THEREFORE, IT IS POSSIBLE THAT NO IMAGE OCCURRED BECAUSE THE VIDEO FUNCTION DID NOT OPERATE NORMALLY DUE TO THE FAILURE OF THE CCD. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS INSPECTED AT OAZ. OAZ CHECKED THE SUBJECT DEVICE AND FOUND THE REPORTED PHENOMENA AND THE SCOPE COMMUNICATION ERROR E226 WAS CAUSED BY THE FAILURE OF THE CABLE AND "NO IMAGE" WAS CAUSED BY THE FAILURE OF THE CCD. 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 THAT DURING THE INCOMING INSPECTION FOR REPAIR AT THE SERVICE DEPARTMENT OF OLYMPUS AUSTRALIA (OAZ), IT WAS FOUND THAT THE SCOPE COMMUNICATION ERROR E226 OCCURRED AND THE ENDOSCOPIC IMAGE WAS NOT DISPLAYED. THE SUBJECT DEVICE HAD BEEN RETURNED TO OAZ FOR REPAIR OF THE FLICKERING IMAGE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1938373 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