BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS VISERA LAPARO-THORACO VIDEOSCOPE

    MDR report key: 2800289 · Received October 9, 2012

    Report

    Report Number
    8010047-2012-00340
    Event Type
    Malfunction
    Date Received
    October 9, 2012
    Date of Event
    August 28, 2012
    Report Date
    September 10, 2012
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION CONFIRMED THAT A PART OF THE BENDING SECTION COVER GLUE WAS MISSING OFF ON THE DISTAL END AREA. ADDITIONALLY, THERE WERE SOME DENTS AND SCRATCHES ON THE SURFACE OF THE BENDING SECTION COVER AND GLUE. THE CAUSE OF THE USER'S EXPERIENCE WAS LIKELY DUE TO PHYSICAL DAMAGE TO THE BENDING SECTION WHEN THE PHYSICIAN WITHDREW THE ENDOSCOPE FROM A TROCAR. 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 AN UNSPECIFIED LAPAROSCOPY PROCEDURE, THE PHYSICIAN NOTICED A BLACK FRAGMENT IN THE PT'S BODY CAVITY. THE PHYSICIAN RETRIEVED THE FRAGMENT DURING THE PROCEDURE BY AN UNKNOWN MEANS. THERE WAS NO PT INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1