BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG SCISSORS 5MM O.D., HF SERIES

    MDR report key: 3173501 · Received June 12, 2013

    Report

    Report Number
    8010047-2013-00155
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 20, 2013
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. FOR EVAL. THE EVAL CONFIRMED THAT THE PROBE BROKE DOWN AT 10 MM FROM THE DISTAL END. THERE WAS A SCRATCH AT THE BROKEN POINT. THE SHAPE OF THE FRACTURED SURFACE SHOWED THAT THE FRACTURE DEVELOPED FROM THE SCRATCH AS THE STARTING POINT. THE MFG HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. AS THE RESULT OF EVAL, WE HAVE CONCLUDED THAT THE PROBE PRESUMABLY WAS SCRATCHED BECAUSE THE PHYSICIAN ACTIVATED ULTRASOUND OUTPUT WHILE THE PROBE WAS IN CONTACT WITH METAL SUCH AS A CLIP AND FORCEPS OR THE PHYSICIAN SCRAPE THE PROBE WITH A SHARP OBJECT SUCH AS A SCALPEL. IN ADDITION, SINCE THE PHYSICIAN CONTINUED TO USE THE SCRATCHED DEVICE, THE CRACK OF THE PROBE OCCURRED. CONSEQUENTLY, THE WARNING ALARM SOUNDED AND THE PROBE TIP BROKE. THE INSTRUCTION MANUAL OF SONOSURG SCISSORS ALREADY STATES; WARNING: DO NOT CONTACT THE PROBE WITH ANY HARD OBJECTS (E.G. METAL CLIPS OR OTHER INSTRUMENTS), AND DO NOT GRASP IT WHEN ULTRASONIC OUTPUT IS ACTIVATED. BE CAREFUL TO AVOID CONTACTING THE PROBE ACCIDENTALLY. THE PROBE AND THE GRASPING SURFACE (WHITE PART) COULD BE WORN AWAY BY ULTRASONIC VIBRATION, WHICH MAY LEAD TO A DAMAGE OR DETACHMENT. BASED UPON THE FINDING OF THE EVAL, THIS REPORT APPEARS TO BE RELATED TO USER MISHANDLING. 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 CHOLECYSTECTOMY, THE PHYSICIAN HEARD A HIGH-PITCHED TONE AND THE OUTPUT OF SUBJECT DEVICE STOPPED. AFTER THAT, THE PHYSICIAN WITHDREW THE SUBJECT DEVICE AND CONFIRMED THAT THE PROBE TIP BROKE. THE BROKEN PIECE OF THE PROBE WAS TAKEN OUT. THE PHYSICIAN REPLACED THE SUBJECT DEVICE WITH A SIMILAR DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267216 SONOSURG SCISSORS 5MM O.D., HF SERIES SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORPORATION T3905 NA

    Patients

    Seq Age Sex Outcome Treatment
    1