BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD AUTOCLAVABLE CAMERA HEAD

    MDR report key: 13111656 · Received December 29, 2021

    Report

    Report Number
    8010047-2021-16938
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Report Date
    May 2, 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
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND CORRECTION TO G3. CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE 26-SEPT-2021. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE MET ALL SPECIFICATIONS AT THE TIME OF SHIPMENT. IT HAS BEEN NEARLY 8 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE SPECIFIC ROOT CAUSE OF THE RUSTED COUPLER COULD NOT BE DETERMINED AT THIS TIME. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE. INVESTIGATION ACTIVITIES HAVE BEEN OPENED TO MANAGE THE ACTIONS RELATED TO THIS REPORT AND ANY REQUIRED MDR REPORTING.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS EVALUATED BY OLYMPUS. THE EVALUATION FOUND RUST ON THE SHAFT OF THE COUPLER AND THE COUPLER FAILED TO RETURN TO THE EXPECTED POSITION DUE TO THE RUST. THE INVESTIGATION IS ONGOING AND THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    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 "COUPLER ABNORMAL." UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS NOTED THAT RUST WAS PRESENT ON THE SHAFT OF THE COUPLER. THIS REPORT IS SUBMITTED DUE TO THE MALFUNCTION OF RUST ON THE SHAFT OF THE COUPLER. THERE WAS NO PATIENT INJURY, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010597 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