BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG SCISSORS 5MM O.D., HF SERIES

    MDR report key: 4370568 · Received December 19, 2014

    Report

    Report Number
    8010047-2014-00998
    Event Type
    Malfunction
    Date Received
    December 19, 2014
    Date of Event
    October 18, 2011
    Report Date
    January 12, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORP.(OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND FOUND THAT THIS SUPPLEMENTAL REPORT IS REQUIRED ON DECEMBER 21ST, 2015. THIS IS A SUPPLEMENTAL REPORT FOR MFR REPORT # 8010047-2014-00998 TO CORRECT DATE RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORPORATION FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PROBE BROKE DOWN. THERE WAS 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 PROBE TIP PRESUMABLY WAS SCRATCHED BECAUSE, THE PHYSICIAN ACTIVATED SEAL AND CUT MODE OUTPUT WHILE THE PROBE TIP WAS IN CONTACT WITH METAL SUCH AS A CLIP AND FORCEPS. AFTER THAT, SINCE THE PHYSICIAN CONTINUED TO USE THE DEVICE, THE CRACK OCCURRED AND THE PROBE BROKE. 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.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING AN UNCERTAIN SURGERY, THE DISTAL END OF THE DEVICE WAS BROKEN OFF. THERE WAS NO REPORT OF PATIENT INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837913 SONOSURG SCISSORS 5MM O.D., HF SERIES SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORPORATION T3935 NA

    Patients

    Seq Age Sex Outcome Treatment
    1