BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 12620558 · Received October 12, 2021

    Report

    Report Number
    8010047-2021-13075
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    September 16, 2021
    Report Date
    December 24, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K955404
    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) FOR EVALUATION. OAZ CHECKED THE SUBJECT DEVICE AND FOUND THE REPORTED PHENOMENON. OMSC CHECKED THE DEVICE HISTORY RECORD OF THE SUBJECT DEVICE, THERE WAS NO IRREGULARITY FOUND. BASED ON THE INFORMATION PROVIDED BY OAZ, OMSC SURMISED THAT THE IMAGE WAS NOT DISPLAYED DUE TO A COMMUNICATION FAILURE CAUSED BY THE PARTIAL CABLE BREAK. THE EXACT CAUSE OF THE PARTIAL CABLE BREAK COULD NOT BE CONCLUSIVELY DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS PLANNED TO BE RETURNED TO OLYMPUS BUT HAS NOT BEEN RETURNED YET.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 BY THE USER THAT DURING THE PREPARATION FOR USE, THE ENDOSCOPIC IMAGE OF THE SUBJECT DEVICE WAS NOT DISPLAYED.THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514910 HD AUTOCLAVABLE CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. OTV-S7PROH-HD-12E

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown