BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS VIDEOSCOPE CABLE FOR EVIS EXERA II

    MDR report key: 2496479 · Received March 13, 2012

    Report

    Report Number
    8010047-2012-00068
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Report Date
    February 13, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KQM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS FOLLOWED-UP WITH THE USER FACILITY VIA TELEPHONE AND IN WRITING TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS REPORT WITHOUT SUCCESS. THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE USERS' EXPERIENCED COULD NOT BE CONCLUSIVELY DETERMINED. IF SIGNIFICANT ADDITIONAL INFORMATION IS RECEIVED AT A FUTURE DATE, THIS REPORT WILL BE SUPPLEMENTED. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNIDENTIFIED ENDOSCOPIC PROCEDURE, THE USERS EXPERIENCED A COMPLETE LOSS OF IMAGE. THE INTENDED PROCEDURE WAS SAID TO HAVE BEEN COMPLETED WITH AN UNSPECIFIED PENTAX ENDOSCOPE WITH NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VIDEOSCOPE CABLE FOR EVIS EXERA II VIDEOSCOPE CABLE KQM OLYMPUS MEDICAL SYSTEMS CORPORATION MAJ-1430 NA

    Patients

    Seq Age Sex Outcome Treatment
    1