BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD 3CMOS AUTOCLAVABLE CAMERA HEAD

    MDR report key: 18803490 · Received February 28, 2024

    Report

    Report Number
    3002808148-2024-31054
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Report Date
    April 5, 2024
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170393204
    PMA / PMN Number
    K200542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UPS MADE TO GATHER ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT, HOWEVER, TO DATE , NO RESPONSE HAS BEEN RECEIVED. THE SUBJECT DEVICE HOWEVER , WAS RECEIVED, AND THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION .

    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 REPORTED FAILURE WAS NOT CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. THREE ATTEMPTS WERE PERFORMED TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. OLYMPUS WILL CONTINUE TO MONITOR THE PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SUBJECT DEVICE HAD AN ISSUE OF "WHOLE IMAGE TURNED GREEN WHEN INDOCYANINE GREEN (ICG) WAS USED IN LAPAROSCOPY CASE (DIAGNOSTIC PROCEDURE). THERE WAS NO PATIENT IMPACT IN THIS REPORTED EVENT. NO HARM REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SUBJECT DEVICE HAD AN ISSUE OF "WHOLE IMAGE TURNED GREEN WHEN INDOCYANINE GREEN (ICG) WAS USED IN LAPAROSCOPY CASE (DIAGNOSTIC PROCEDURE). THERE WAS NO PATIENT IMPACT IN THIS REPORTED EVENT. NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744765 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 INDOCYANINE GREEN (ICG) (DYE)