BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG SCISSORS 5MM O.D., HF SERIES

    MDR report key: 3131540 · Received May 15, 2013

    Report

    Report Number
    8010047-2013-00128
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 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 A SCRATCH AT THE BROKEN POINT. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT THE FRACTURE DEVELOPED FROM THE SCRATCHED AS THE STARTING POINT. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. AS THE RESULT OF EVALUATION, WE HAVE CONCLUDED THAT THE PROBE PRESUMABLY WAS SCRATCHED AND CRACKED 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 PROBE TIP WAS DETACHED. THE INSTRUCTION MANUAL OF SONOSURG SCISSORS MENTIONS WARNING AND CAUTION FOR POSSIBLE MISHANDLING MENTIONED ABOVE. 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 PROCEDURE, THE PROBE BROKE AND FELL OFF INTO THE PATIENT'S BODY. 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
    215928 SONOSURG SCISSORS 5MM O.D., HF SERIES SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORPORATION T3905 NA

    Patients

    Seq Age Sex Outcome Treatment
    1