BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OLYMPUS ELECTROSURGICAL UNIT UES-40

    MDR report key: 2200766 · Received July 28, 2011

    Report

    Report Number
    8010047-2011-00177
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    August 26, 2010
    Report Date
    June 29, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVAL. THE UNIT PASSED ALL FUNCTIONAL TESTS WITH NO ABNORMALITIES OBSERVED. THE SUBJECT DEVICE REPORTEDLY SIGNALED AN ALARM WHILE THE USERS WERE CUTTING AND COAGULATING. THE CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED BUT USER ERROR COULD NOT BE RULED OUT AS A CONTRIBUTORY FACTOR. THE DEVICE INSTRUCTION MANUAL ADVISES THE USERS ON THE DESCRIPTION AND SOLUTION OF THE ERROR MESSAGES. THIS REPORT IS BEING SUBMITTED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE PT REPORTEDLY HAD ABDOMINAL PAIN AND EXTRA VESICAL URINAL LEAKAGE FOLLOWING A THERAPEUTIC BIPOLAR PROSTATE RESECTION PROCEDURE. THE PT HAD MUCOSA NECROSIS OF THE URETHRA AND BLADDER DOME WHICH RESULTED IN URETHRA STENOSIS AND DISCONNECTION OF THE VESICAL NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS ELECTROSURGICAL UNIT UES-40 ELECTROSURGICAL UNIT KNS OLYMPUS MEDICAL SYSTEMS CORPORATION UES-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization AN OLYMPUS (B)(4) ELECTRODE WITH UNK LOT NUMBER