BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 3CMOS AUTOCLAVABLE CAMERA HEAD

    MDR report key: 19075960 · Received April 9, 2024

    Report

    Report Number
    3002808148-2024-32066
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    February 9, 2024
    Report Date
    April 9, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170393204
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DOCUMENTED HERE DUE TO CURRENT SYSTEM LIMITATION: E2 (HEALTH PROFESSIONAL): NO. E3 (OCCUPATION): NON-HEALTH PROFESSIONAL. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. IN ADDITION, NEW DAMAGES/DEFECTS WERE OBSERVED: CABLE LEAKAGE. A DEVICE HISTORY REVIEW - DHR WAS CONDUCTED, AND NO ISSUES WERE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, NO NONCONFORMITIES WERE FOUND RELATED TO THIS COMPLAINT OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT PRODUCT EXHIBITED A CABLE LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512976 HD 3CMOS AUTOCLAVABLE CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. CH-S200-XZ-EA 04953170393204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown