BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SONOSURG SCISSORS, 5MM OD, NON HF SER

    MDR report key: 1430150 · Received April 28, 2009

    Report

    Report Number
    8010047-2009-00081
    Event Type
    Malfunction
    Date Received
    April 28, 2009
    Date of Event
    February 17, 2009
    Report Date
    February 18, 2009
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WILL BE FORWARDED TO OLYMPUS AMERICA, INC., FOR FURTHER EVAL. IF THE DEVICE IS RECEIVED AT A LATER DATE, AND FURTHER SIGNIFICANT ADDITIONAL INFO BECOMES AVAILABLE, THE REPORT WILL BE UPDATED. THE CAUSE OF THE USER'S EXPERIENCE COULD NOT CONCLUSIVELY BE DETERMINED AT THIS TIME. 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 THE TIP OF THE SONOSURG SCISSORS HAD BROKEN DURING A THERAPEUTIC LAPAROSCOPIC SIGMOID BOWEL RESECTION, AND HAD FALLEN INTO THE PT. THE DETACHED TIP WAS REPORTEDLY RETRIEVED WITH NO PT INJURY REPORTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT, BUT SIMILAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS SONOSURG SCISSORS, 5MM OD, NON HF SER SURGICAL SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORPORATION T3075 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK A SONOSURG HANDPIECE WAS USED DURING THE PROCEDURE