BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG SCISSORS 5MM O.D., HF SERIES

    MDR report key: 3171861 · Received May 23, 2013

    Report

    Report Number
    8010047-2013-00120
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 26, 2013
    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 OLYMPUS MEDICAL SYSTEMS CORPORATION FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PROBE BROKE DOWN AT 15.5 MM FROM THE DISTAL END. THERE WAS NO SCRATCH OR CRACK FOUND IN THE FRACTURES SURFACE. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT THE FRACTURE DEVELOPED FROM THE SIDE SURFACE OF THE PROBE. THERE WAS NO SIGNIFICANT WEAR OF PTFE PAD. THE MFG HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. AS THE RESULT OF EVALUATION, IT IS HIGHLY LIKELY THAT THE PHYSICIAN ACTIVATED THE ULTRASONIC OUTPUT WHILE THE SUBJECT DEVICE WAS TWISTED AND THE STRESS WAS PUT ON THE PROBE, RESULTED IN BREAK. THE INSTRUCTION MANUAL OF SONOSURG SCISSORS PROHIBITS THE USAGE AS MENTIONED IN THE ABOVE, AND DESCRIBES HOW TO DEAL WITH WHEN AN IRREGULARITY IS FOUND ON THE PROBE IS BROKEN. BASED UPON THE FINDING OF THE EVALUATION, 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

    WHEN A PHYSICIAN USED THE SUBJECT DEVICE FOR A LAPAROSCOPIC MYOMECTOMY, THE PROBE BROKE AND FELL OFF INTO THE PT'S BODY. THE BROKEN PIECE OF THE PROBE WAS TAKEN OUT. THE PHYSICIAN REPLACED THE SUBJECT DEVICE WITH A SIMILAR DEVICE. THE PROCEDURE WAS COMPLETED AS SCHEDULED. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228205 SONOSURG SCISSORS 5MM O.D., HF SERIES SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORPORATION T3905 NA

    Patients

    Seq Age Sex Outcome Treatment
    1