BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG SCISSORS 5MM O.D. HF SERIES

    MDR report key: 3770272 · Received March 7, 2014

    Report

    Report Number
    8010047-2014-00096
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 19, 2014
    Report Date
    February 21, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVAL. THE EVAL CONFIRMED THAT THE PROBE BROKE DOWN AT 15 MM FROM THE DISTAL END. THERE WERE NOT ANY SCRATCHES AT THE BROKEN POINT. THE MFG HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. AS THE RESULT OF THE EVAL, SINCE THERE WERE NOT ANY SCRATCHES AT THE BROKEN POINT, WE HAVE CONCLUDED THAT THE PROBE WAS CRACKED DUE TO ACTIVATING THE ULTRASOUND OUTPUT WITH STRONG FORCE OR TWISTING THE SUBJECT DEVICE GRASPING A TISSUE, AND EVENTUALLY BROKE DUE TO ACTIVATING THE ULTRASOUND OUTPUT CONTINUOUSLY USING THE CRACKED PROBE. IT IS CONSIDERED THAT THE ABNORMAL SOUND OCCURRED WHEN ACTIVATING THE ULTRASOUND OUTPUT WITH THE CRACKED PROBE. THE INSTRUCTION MANUAL OF SONOSURG SCISSORS MENTIONS WARNING AND CAUTION FOR POSSIBLE MISHANDLING MENTIONED ABOVE. BASED UPON THE FINDING OF EVAL, IMPROPER HANDLING THE SUBJECT DEVICE CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THIS EVENT. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEM CORPO (OMSC) WAS INFORMED THAT DURING MUSCLE-PRESERVING MASTECTOMY, AN ABNORMAL SOUND OCCURRED AND THE PROBE OF THE SUBJECT DEVICE BROKE. THE BROKEN PROBE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED WITH OTHER DEVICE. THERE WAS NO REPORT OF INJURY REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139616 SONOSURG SCISSORS 5MM O.D. HF SERIES SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORPORATION T3955 NA

    Patients

    Seq Age Sex Outcome Treatment
    1