BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS SONOSURG SCISSORS

    MDR report key: 2318550 · Received October 19, 2011

    Report

    Report Number
    8010047-2011-00243
    Event Type
    Malfunction
    Date Received
    October 19, 2011
    Date of Event
    September 20, 2011
    Report Date
    September 21, 2011
    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 WAS RETURNED TO OLYMPUS (B)(4) FOR EVAL. THE EVAL REVEALED THAT THE HINGE ON THE GRASPING SECTION OF THE SONOSURG SCISSORS WAS MISSING, WHICH CAUSED THE GRASPING SECTION TO FALL BACKWARD. THE SONOSURG PROBE WAS NOT RETURNED FOR EVAL, AND OCI WAS INFORMED BY THE USER FACILITY THAT THE BROKEN TIP OF THE SONOSURG PROBE HAS BEEN DISCARDED FOLLOWING THE PROCEDURE. THE RETURNED PORTION OF THE SUBJECT DEVICE WILL BE FORWARDED TO OLYMPUS AMERICA, INC. (OAI) FOR FURTHER INVESTIGATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME, IF SIGNIFICANT AND RELEVANT INFO BECOMES AVAILABLE LATER, THIS REPORT WILL THEN BE SUPPLEMENTED. 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 THERAPEUTIC INTESTINAL RESECTION BY LAPAROSCOPY, THE TIP OF SONOSURG PROBE FELL OFF INTO PT AND WAS RETRIEVED BY UNK DEVICE. THE PROCEDURE WAS COMPLETED DURING AN UNK DEVICE. 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 T3075 NA

    Patients

    Seq Age Sex Outcome Treatment
    1