BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HD CAMERA HEAD

    MDR report key: 16137322 · Received January 11, 2023

    Report

    Report Number
    3002808148-2023-00295
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 16, 2022
    Report Date
    February 28, 2023
    Manufacturer
    SHIRAKAWA OLYMPUS CO., LTD.
    Product Code
    FET
    UDI-DI
    04953170336669
    PMA / PMN Number
    K102059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE PRIOR TO THE CONCLUSION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. IT HAS BEEN OVER 5 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. THE SUBJECT DEVICE WAS RETURNED. BASED ON THE RESULTS OF THE LEGAL MANUFACTURER'S INVESTIGATION, POOR WATER TIGHTNESS OF THE PRODUCT HAS BEEN CONFIRMED, AND CABLES, CONNECTORS, AND CHARGE-COUPLED DEVICE (CCD) LENSES HAVE BEEN FOUND TO BE DEFECTIVE IN APPEARANCE/PRODUCT TIGHTNESS. THEREFORE, THERE IS A POSSIBILITY THAT THE SUBSTRATES WERE DAMAGED BY IMMERSION DUE TO POOR WATER TIGHTNESS, AND IT WAS LIKELY THAT THE IMAGE FUNCTION DID NOT OPERATE NORMALLY DUE TO PARTIAL WATER IMMERSION FAILURE OF THE SUBSTRATE CAUSING THE PHENOMENON ¿THERE IS A PROBLEM WITH THE IMAGE¿ TO OCCUR. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT HIS OLYMPUS HD CAMERA HEAD WAS NOT DISPLAYING AN IMAGE. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER STATING THAT THE INTENDED PROCEDURE WAS COMPLETED WITHOUT DELAY. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908871 HD CAMERA HEAD AUTOCLAVABLE CAMERA HEAD FET SHIRAKAWA OLYMPUS CO., LTD. CH-S190-08-LB 04953170336669

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown