BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE

    MDR report key: 2910623 · Received December 4, 2012

    Report

    Report Number
    8010047-2012-00439
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    September 5, 2012
    Report Date
    November 7, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED A VERTICALLY DISTORTED IMAGE. THE IMAGE DIDN'T CHANGE, WHEN MANIPULATING A BENDING SECTION AND A LIGHT GUIDE CABLE. THE DEVICE PASSED LEAK TEST. THE IMAGE DIFFICULTY IS LIKELY ATTRIBUTED TO A DAMAGED CHARGED COUPLED DEVICE (CCD). AT THE PRESENT TIME, THE EXACT CAUSE OF THE DAMAGED CCD CANNOT BE DETERMINED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A LAPAROSCOPIC ADRENALECTOMY, A PHYSICIAN EXPERIENCED AN ABNORMALLY BLUISH IMAGE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SIMILAR DEVICE. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE LAPAROSCOPE KOG OLYMPUS MEDICAL SYSTEMS CORPORATION LTF-S190-5

    Patients

    Seq Age Sex Outcome Treatment
    1