BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 3CMOS AUTOCLAVABLE CAMERA HEAD

    MDR report key: 12757025 · Received November 7, 2021

    Report

    Report Number
    8010047-2021-14125
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 21, 2021
    Report Date
    January 21, 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. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS AUSTRALIA & NEW ZEALAND (OAZ). OMSC CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT DEVICE, THERE WAS NO IRREGULARITY FOUND. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED ON THE INFORMATION PROVIDED BY OAZ, THE CABLE UNIT HAD BEEN REPLACED, AND OMSC SURMISED THAT A COMMUNICATION FAILURE CAUSED BY A CABLE UNIT FAILURE RESULTED IN COMMUNICATION ERROR E226. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION BUT WAS RETURNED TO OLYMPUS (B)(4). (B)(4) CHECKED THE SUBJECT DEVICE AND DUPLICATED THE REPORTED PHENOMENON. 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 · 0

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE USER THAT DURING THE PROCEDURE, THE SCOPE COMMUNICATION ERROR E226 WAS DISPLAYED ON THE MONITOR. ERROR CODE E226 MEANS THAT THE COMMUNICATION BETWEEN THE ENDOSCOPE AND VIDEO SYSTEM CENTER HAS FAILED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1659362 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