BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 14161264 · Received April 20, 2022

    Report

    Report Number
    8010047-2022-06694
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Report Date
    June 9, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170310799
    PMA / PMN Number
    K102059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY OLYMPUS. THE EVALUATION FOUND RUST ON THE SHAFT OF THE COUPLER. ADDITIONAL EVALUATION FINDINGS ARE AS FOLLOWS: CONTROL UNIT APPEARANCE DEFECTS; AIR/WATER LEAKAGE; IMAGE QUALITY ABNORMAL DUE TO WHITE DOT. THE INVESTIGATION IS ONGOING AND THE DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 22-MARCH-2022. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE DEFINITIVE ROOT CAUSE OF THE CORROSION COULD NOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    A USER FACILITY RETURNED THE OLYMPUS, MODEL CH-S190-XZ-E, HD AUTOCLAVABLE CAMERA HEAD TO OLYMPUS FOR REPAIR DUE TO A REPORT OF A "CRACK ON CAMERA HEAD." UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, RUST WAS FOUND ON THE SHAFT OF THE COUPLER. THIS REPORT IS SUBMITTED DUE TO THE RUST FOUND ON THE SHAFT OF THE COUPLER. AS THE PROBLEM WAS FOUND DURING IN-HOUSE SERVICE OF THE DEVICE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2719576 HD AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S190-XZ-E 04953170310799

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown