BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG SCISSORS 5 MM O.D., HF SERIES

    MDR report key: 3961406 · Received May 30, 2014

    Report

    Report Number
    8010047-2014-00298
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 10, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 16.5 MM FROM THE DISTAL END. THERE WAS A SCRATCH, WHICH MAY LEAD TO THE FRACTURE, AROUND THE BROKEN POINT. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT THE CRACKS DEVELOPED FROM THE SCRATCH AS THE STARTING POINT. 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 USER USED THE DEVICE HAVING THE SCRATCHED PROBE CONTINUOUSLY, THEN THE CRACKS DEVELOPED BY PHYSICAL STRESS DURING THE PROCEDURE. AFTER THAT, THE PROBE BROKE DUE OT THE STRESS BEYOND TOLERANCE ON THE BROKEN POINT WHEN THE PHYSICIAN WIPED IT. BASED UPON THE FINDING OF THE EVAL, THIS REPORT APPEARS TO BE RELATED TO USER HANDLING. THIS REPORT IS BEING SUBMITTED AAS 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 LAPAROTOMY OF GASTRECTOMY, AN ERROR CODE DISPLAYED WAS OBSERVED AND THE PHYSICIAN STOPPED USE OF THE SUBJECT DEVICE. WHEN THE NURSE WIPED IT WITH A PIECE OF GAUZE OUTSIDE THE PT, THE PROBE BROKE OFF. 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
    318367 SONOSURG SCISSORS 5 MM O.D., HF SERIES SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORPORATION T3925 NA

    Patients

    Seq Age Sex Outcome Treatment
    1