BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD CAMERA HEAD

    MDR report key: 19084197 · Received April 10, 2024

    Report

    Report Number
    3002808148-2024-32106
    Event Type
    Malfunction
    Date Received
    April 10, 2024
    Date of Event
    March 12, 2024
    Report Date
    June 4, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVALUATION OF THE EVENT IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AND THE CUSTOMER'S ALLEGATION WAS CONFIRMED. HOWEVER, THE CAMERA CABLE WAS DIRTY. THE MOST PROBABLE CAUSE OF THE IDENTIFIED FAILURES IS CAUSE TRACED TO DEGRADATION, WHICH IS AN EXPECTED OR RANDOM COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE. A DEFINITIVE ROOT CAUSE HOWEVER CANNOT BE IDENTIFIED. A DEVICE HISTORY REVIEW (DHR) WAS COMPLETED, AND NO ISSUES WERE IDENTIFIED. THIS ISSUE IS ADDRESSED IN THE INSTRUCTIONS FOR USE (IFU):** THE FOLLOWING STATEMENT IS INCLUDED IN "CAUTION" IN THE INSTRUCTION MANUAL "APPLICABLE REPROCESSING METHODS AND CHEMICAL AGENTS": THE CAMERA HEAD HAS SEVERAL REPROCESSING METHODS. THE FOLLOWING IS DESCRIBED IN THE INSTRUCTION MANUAL "APPLICABLE REPROCESSING METHODS AND CHEMICAL AGENTS": "SEVERAL REPROCESSING METHODS ARE APPLICABLE TO THE CAMERA HEAD. HOWEVER, NOT ALL METHODS ARE APPLICABLE TO ALL CAMERA HEADS. INAPPLICABLE REPROCESSING METHODS MAY DAMAGE THE EQUIPMENT EVEN IF THE NUMBER OF REPROCESSING CYCLES IS SMALL. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED, AFTER REPROCESSING, STICKINESS WAS CONFIRMED ON THE CAMERA HEAD CABLE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED, AFTER REPROCESSING, STICKINESS WAS CONFIRMED ON THE CAMERA HEAD CABLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1061931 HD CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. CH-S200-08-LB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown