BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG SCISSORS 5 MM O.D., NON HF SERIES

    MDR report key: 3973265 · Received June 6, 2014

    Report

    Report Number
    8010047-2014-00311
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) FOR EVAL. OMSC RECEIVED THE PICTURES OF THE SUBJECT DEVICE AND CONFIRMED THAT THE PTFE PAD ON THE GRASPING SECTION OF THE SUBJECT DEVICE WORN SEVERELY AND THE METAL PART WAS EXPOSED. AND THERE WERE SOME SCRATCHES ON THE PROBE. BASED ON THE PAST CASES WITH THE SAME MODEL, IT IS KNOWN THAT BY CONTINUOUSLY ACTIVATING OUTPUT WITHOUT GRASPING ANYTHING IN THE GRASPING SECTION (INCLUDING AFTER THE TISSUE SEPARATED), THE PTFE PAD SEVERELY WEARS. CONSIDERING THE INSPECTION RESULT OF THE SUBJECT DEVICE, OMSC CONCLUDED THAT THE REPORTED EVENT OCCURRED SINCE THE PTFE PAD WORE SEVERELY AND BECAME THIN, THE PROBE AND GRASPING SECTION BECAME CONTACTING EACH OTHER, AND ERROR DISPLAYED. THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE ALREADY WARNS; DO NOT ACTIVATE OUTPUT UNLESS THE GRASPING SECTION IS HOLDING THE TISSUE. STOP OUTPUT IMMEDIATELY AFTER CUTTING THE TISSUE. DO NOT ACTIVATE OUTPUT UNLESS IT IS POSSIBLE TO CONFIRM THAT THE TISSUE IS SECURELY GRASPED. BASED UPON THE FINDING OF THE INSPECTION, THIS REPORT APPEARS TO BE RELATED TO USER HANDLING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT THE PHYSICIAN COULD NOT USE THE SUBJECT DEVICE. THE DEVICE WAS USED SEVEN TIMES. THERE WAS NEITHER THE BROKEN OFF THE PROBE NOR THE DETACHMENT OF THE PARTS. THERE WAS NO REPORT OF PT'S INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331542 SONOSURG SCISSORS 5 MM O.D., NON HF SERIES SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORPORATION T3075 NA

    Patients

    Seq Age Sex Outcome Treatment
    1