BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG SCISSORS 5MM O.D., HF SERIES

    MDR report key: 2843695 · Received October 26, 2012

    Report

    Report Number
    8010047-2012-00364
    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 FIRST PROBE WAS CRACKED AT 15.5 MM FROM THE DISTAL END. AND THERE WAS NOT A SCRATCH AT THE BROKEN POINT. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. AS THE RESULT OF EVALUATION, WE HAVE CONCLUDED THAT THE FIRST PROBE WAS CRACKED AN THE FIRST DEVICE WAS NOT ACTIVATED OUTPUT DUE TO THE DISPLAY OF ULTRASONIC OUTPUT WARNING. 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 TIP, OR THE STRESS WAS PUT ON THE PROBE TIP DURING CLEANING, RESULTED IN CRACKED. THE INSTRUCTION MANUAL OF (B)(4) SCISSORS ALREADY STATES; WARNING: DO NOT ACTIVATE ULTRASONIC OUTPUT WHILE TWISTING THE INSERTION SECTION OR TURNING THE ROTATABLE KNOB. DOING SO COULD DAMAGE THE PROBE. 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. THIS REPORT IS ONE OF FOUR REPORTS. CROSS REFERENCE MFR. REPORT NUMBER 8010047-2012-00365, 00379, 00380.

    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