BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS VISERA LAPARO-THORACO VIDEOSCOPE

    MDR report key: 2112482 · Received May 24, 2011

    Report

    Report Number
    8010047-2011-00104
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 25, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    Adverse Event
    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 MEDICAL SYSTEMS CORPORATION FOR EVALUATION. THE EVALUATION CONFIRMED THAT PART OF THE BENDING SECTION COVER GLUE WERE MISSING ON BOTH THE DISTAL END AND PROXIMAL END AREA. THIS PHENOMENON LIKELY OCCURRED WHEN THE PHYSICIAN WITHDREW THE ENDOSCOPE FROM THE TROCAR. THE DEVICE WAS SERVICED AND RETURNED TO THE USER FACILITY. 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 A PORTION OF THE BENDING SECTION COVER GLUE CAME OFF DURING AN UNSPECIFIED PROCEDURE, AND FELL INTO THE PT. THE PHYSICIAN RECOVERED THE FRAGMENT USING AN UNSPECIFIED DEVICE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VISERA LAPARO-THORACO VIDEOSCOPE LAPARO-THORACO VIDEOSCOPE GCJ OLYMPUS MEDICAL SYSTEMS CORP. LTF-VP N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CONMED'S TROCAR: MODEL UNK