BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD CAMERA HEAD

    MDR report key: 19219760 · Received May 1, 2024

    Report

    Report Number
    3002808148-2024-32583
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    April 2, 2024
    Report Date
    June 10, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170336669
    PMA / PMN Number
    K102059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    IN SPEAKING WITH OLYMPUS TECHNICAL SUPPORT VIA PHONE, THE CUSTOMER WAS ADVISED TO CALL OLYMPUS SERVICE DEPARTMENT TO SETUP A RETURN MATERIAL AUTHORIZATION FOR REPAIR OF THE PRODUCT. THE CUSTOMER FELT THIS WAS AN OLYMPUS QUALITY ISSUE AND WOULD LIKE THIS TO BE ASSOCIATED TO OTHER COMPLAINTS FOR OTHER MODEL CAMERA HEADS WITH SIMILAR ISSUES. 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 SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE RESULTS OF THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION, AND THE REPORTABLE MALFUNCTION WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: CAUSE NOT ESTABLISHED. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: CAMERA HEAD (CH-S190-08-LB) IS NOT COMPATIBLE WITH STERIS V-PRO", REPEATED USE AND REPROCESSING OF CAMERA HEADS LEADS TO GRADUAL WEAR AND TEAR. FURTHERMORE, REPROCESSING METHODS THAT EMPLOY HIGHER TEMPERATURES AND MORE CAUSTIC/CORROSIVE MATERIALS MAY LEAD TO FASTER DETERIORATION AND THE USE OF NON-OEM MATERIALS TO REPAIR AN OLYMPUS DEVICE MAY AFFECT THE MATERIAL COMPATIBILITY OF THE DEVICE WITH CERTAIN REPROCESSING CHEMICALS OR METHODS. 3.1 COMPATIBILITY SUMMARY. (REPROCESSING MANUAL) OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CAMERA HEAD MALFUNCTIONED AND NOTICED BUCKLING ON THE CORD AND A SMALL HOLE UNDER THE BOOT OF THE ELECTRICAL CONNECTOR. THE ISSUE HAPPENED DURING PREPARATION (AFTER WASHING AND PACKING FOR STERILIZATION) PRIOR TO IN AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE DAMAGE WAS NOT ON THE CORD WHEN MANUAL CLEANING WAS COMPLETED AND PLACED IN THE STERILIZATION TRAY. THE DAMAGE WAS NOTICED WHEN THE CASE WAS OPENED BY THE OPERATING ROOM STAFF RIGHT BEFORE THE PROCEDURE TOOK PLACE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CAMERA HEAD MALFUNCTIONED AND NOTICED BUCKLING ON THE CORD AND A SMALL HOLE UNDER THE BOOT OF THE ELECTRICAL CONNECTOR. THE ISSUE HAPPENED DURING PREPARATION (AFTER WASHING AND PACKING FOR STERILIZATION) PRIOR TO IN AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE DAMAGE WAS NOT ON THE CORD WHEN MANUAL CLEANING WAS COMPLETED AND PLACED IN THE STERILIZATION TRAY. THE DAMAGE WAS NOTICED WHEN THE CASE WAS OPENED BY THE OPERATING ROOM STAFF RIGHT BEFORE THE PROCEDURE TOOK PLACE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172275 HD CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. CH-S190-08-LB 04953170336669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown STERIS V-PRO