BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG SCISSORS 5 MM O.D., HF SERIES

    MDR report key: 3961392 · Received May 30, 2014

    Report

    Report Number
    8010047-2014-00303
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVAL. THE EVAL CONFIRMED THAT THE PROBE BROKE OFF AT 17 MM FROM THE DISTAL END. THERE WAS NO SCRATCH, WHICH MAY LEAD TO THE FRACTURE, AROUND THE BROKEN POINT. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT A CRACK SPREAD FROM THE STARTING POINT OF THE FRACTURE. AND THERE WAS A COARSE PART ON THE FRACTURE SURFACE WHICH SHOWED THAT IT FRACTURED BY PHYSICAL STRESS. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. CONSIDERING THE EVAL RESULT OF THE SUBJECT DEICE, OMSC CONCLUDED THAT THE ERROR WAS DUE TO THE CRACK ON THE PROBE. AS A CAUSE OF THE CRACK ON THE PROBE, IT IS POSSIBLE THAT THE USER ACTIVATED THE ULTRASOUND OUTPUT APPLYING ONLY THE PROBE TIP TO THE TISSUE WITH STRONG FORCE OR TWISTING THE DEVICE WHILE GRASPING THE TISSUE. BASED UPON THE FINDING OF THE EVAL, 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 MED SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING A LAPAROSCOPIC ASSISTED DISTAL GASTRECTOMY, ERROR CODES WERE DISPLAYED WHEN THE PHYSICIAN DID INSPECTION OF THE SUBJECT DEVICE BEFORE USE, AND HE STOPPED USE OF IT. THEN HE ACTIVATED THE OUTPUT ON THE OUTSIDE OF THE PT, WITHOUT GRASPING THE TISSUE, AND THE PROBE BROKE OFF. THE DEVICE WAS THE FIRST USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PT INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317965 SONOSURG SCISSORS 5 MM O.D., HF SERIES SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORPORATION T3905 NA

    Patients

    Seq Age Sex Outcome Treatment
    1