BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD CAMERA HEAD

    MDR report key: 19505339 · Received June 10, 2024

    Report

    Report Number
    3002808148-2024-33798
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Report Date
    June 14, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170268267
    PMA / PMN Number
    K083155
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INFORMATION AVAILABLE FOR THE OCCUPATION OF THE INITIAL REPORTER OR WHETHER THEY ARE A HEALTHCARE PROFESSIONAL THE INVESTIGATION 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. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS, THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. AND THE REPORTABLE MALFUNCTION WAS CONFIRMED. ADDITIONALLY, THE LENS WAS FLOODED, THE IMAGE WAS DIM AND THE SCOPE MOUNT WAS RATTLING. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT IS LIKELY, THAT THE LENS WAS REMOVED, THE AIRTIGHTNESS COULD NOT BE MAINTAINED, MOISTURE ENTERED THE INTERNAL PARTS. AND THE LENS WAS FLOODED, CAUSING THE IMAGE TO BE DIMMED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SUBJECT DEVICE HAD THE LENS COME OFF. IT IS UNSPECIFIED WHEN THE ISSUE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM.

    Description of Event or Problem · 0

    IT WAS REPORTED, THE SUBJECT DEVICE HAD THE LENS COME OFF. THE ISSUE WAS FOUND, DURING A THERAPEUTIC TRANSURETHRAL RESECTION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITH NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11626 HD CAMERA HEAD CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. OTV-S7PROH-HD-L08E 04953170268267

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown