BEUDAMED
    FDA Adverse Event Other Summary report: N

    OLYMPUS SONOSURG SCISSORS

    MDR report key: 2181514 · Received May 25, 2011

    Report

    Report Number
    8010047-2011-00105
    Event Type
    Other
    Date Received
    May 25, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 26, 2011
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REFERENCED DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP (OMSC) FOR EVAL. THE EVAL FOUND A BROKEN PIN, BENT GRASPING PORTION, AND SCRATCH MARK ON THE GRASPING PORTION OF THE DEVICE. OMSC ATTRIBUTED THE REPORTED PHENOMENON TO PHYSICAL DAMAGE. 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 NEPHRECTOMY, A DEVICE FRAGMENT FELL INTO THE PT. THE DEVICE FRAGMENT WAS REMOVED USING A GRASPING FORCEPS (MODEL UNK). THE PROCEDURE WAS COMPLETED AND THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SONOSURG SCISSORS SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORPORATION T3105 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other