BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 10904822 · Received November 25, 2020

    Report

    Report Number
    8010047-2020-09464
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    October 28, 2020
    Report Date
    January 7, 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 SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, BUT WAS RETURNED TO OLYMPUS AUSTRALIA (OAZ). OAZ INSPECTED THE SUBJECT DEVICE AND THE REPORTED PHENOMENON WAS DUPLICATED. OMSC REVIEWED THE MANUFACTURING HISTORY (DHR) OF THE SUBJECT DEVICE AND CONFIRMED NO IRREGULARITY. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INSPECTION RESULTS, THERE IS THE POSSIBILITY THAT A FAILURE IN THE CAMERA CABLE AND/OR THE VIDEO CONNECTOR ATTRIBUTED TO THE REPORTED PHENOMENON, BECAUSE THE CABLE AND THE VIDEO CONNECTOR TRANSMIT VIDEO SIGNALS.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN 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 FROM THE USER THAT DURING THE PREPARATION FOR USE, THE ERROR B30 WHICH INDICATED THAT THERE WAS THE COMMUNICATION PROBLEM BETWEEN THE ENDOSCOPE AND VIDEO PROCESSOR WAS DISPLAYED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369687 HD AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S190-XZ-E

    Patients

    Seq Age Sex Outcome Treatment
    1