BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K CAMERA HEAD

    MDR report key: 12131286 · Received July 7, 2021

    Report

    Report Number
    8010047-2021-08532
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 14, 2021
    Report Date
    August 20, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170374609
    PMA / PMN Number
    K172817
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE LEGAL MANUFACTURER (LM) INVESTIGATION. THE LEGAL MANUFACTURER (LM) REVIEWED THE CONTENT OF THIS COMPLAINT FOR FURTHER INVESTIGATION. THE LEGAL MANUFACTURER PROVIDED THE FOLLOWING POSSIBLE CAUSE FOR THE REPORTED EVENT WERE AS FOLLOWS: THE LEGAL MANUFACTURER REPORTED A DHR REVIEW SHOWED THERE WAS NO ABNORMALITY AT THE TIME OF SHIPMENT. SINCE THE FOCUS RING IS CRACKED EXCESSIVE FORCE WAS APPLIED DURING THE USER'S HANDLING. ALSO, RESULTING IN THE CABLE UNIT MALFUNCTIONS, AND E224 ERROR AND THE IMAGE NO LONGER DISPLAYING. AS THE RESULTS OF THE DHR REVIEW, IT WAS CONFIRMED THAT THERE WAS NO ABNORMALITY IN MANUFACTURING, CONCESSION, AND VARIATION.

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED TO THE SERVICE CENTER FOR EVALUATION. THE CUSTOMER¿S COMPLAINT OF A ¿CAMERA HEAD COMMUNICATION ERROR, NO IMAGE" WAS PARTIALLY CONFIRMED. THE UNIT¿S IMAGE APPEARS WITH AN ERROR ¿E224¿ DISPLAYED DUE TO FAULTY CABLE UNIT. IN ADDITION, THE UNIT¿S REAR COVER LABEL WAS FADING AND THE FOCUS RING HAD THIN CRACKS. AN INVESTIGATION IS ONGOING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION IS RECEIVED THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    THE SERVICE CENTER WAS INFORMED AN ¿E222/224 ERROR-SCOPE COMMUNICATION ERROR¿ WAS OBSERVED ON THE UNIT¿S DISPLAY. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028635 4K CAMERA HEAD CAMERA HEAD FET OLYMPUS MEDICAL SYSTEMS CORP. CH-S400-XZ-EB 04953170374609

    Patients

    Seq Age Sex Outcome Treatment
    1