BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG SCISSORS 5MM O.D., HF SERIES

    MDR report key: 2843709 · Received October 26, 2012

    Report

    Report Number
    8010047-2012-00380
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 4, 2012
    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 (OMSC) FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE FOURTH PROBE BROKE DOWN AT 16.0 MM FROM THE DISTAL END. AND THERE WAS A SCRATCH AT THE BROKEN POINT. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. AS THE RESULT OF EVALUATION, THE FOURTH PROBE PRESUMABLY BROKE SINCE THE PROBE WAS DAMAGED BECAUSE THE PHYSICIAN ACTIVATED ULTRASOUND OUTPUT WHILE THE PROBE WAS IN CONTACT WITH METAL SUCH AS A CLIP, AND BESIDES THE PHYSICIAN CONTINUED TO USE THE DAMAGED DEVICE, THE PROBE WAS CRACKED. THE INSTRUCTION MANUAL OF SONOSURG SCISSORS ALREADY STATES; WARNING: DO NOT ACTIVATE ULTRASONIC OUTPUT WHILE GRASPING HARD TISSUE SUCH AS BONE OR CALCIFIED TISSUE WITH THE PROBE. OTHERWISE, THE PROBE MAY BE DAMAGED OR BECOME TOO HOT BEFORE THE OUTPUT WARNING ALARM SOUNDS. BASED UPON THE FINDING OF THE ELEVATION, THIS REPORTING APPEARS TO BE RELATED TO USER HANDLING. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. THIS REPORT IS ONE OF FOUR REPORTS. CROSS REFERENCE MFR. REPORT NUMBER 8010047-2012-00364, 00365, 00379.

    Description of Event or Problem · 1

    WHEN A PHYSICIAN USED THE SUBJECT DEVICE FOR A TOTAL LAPAROSCOPIC HYSTERECTOMY, THE FIRST DEVICE DID NOT ACTIVATE OUTPUT. THE PHYSICIAN USED SECOND DEVICE AND THE PROBE BROKE DURING CLEANING IT OUTSIDE THE PATIENT'S BODY. AFTER THAT THE PHYSICIAN USED THIRD DEVICE AND THE PROBE BROKE AND FELL OFF INSIDE THE PATIENT'S BODY. THE BROKEN PIECE OF THE PROBE WAS TAKEN OUT. AFTER THAT THE PHYSICIAN USED FOURTH DEVICE AND CONFIRMED THAT THE PROBE WAS ABOUT TO BREAK. THE PHYSICIAN WITHDREW FOURTH DEVICE AND REPLACE FIFTH DEVICE. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR