BEUDAMED
    FDA Adverse Event Summary report: N

    SONOSURG SCISSORS 5 MM O.D., HF SERIES

    MDR report key: 4090004 · Received September 5, 2014

    Report

    Report Number
    8010047-2014-00503
    Date Received
    September 5, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 19, 2014
    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

    THE SUBJECT DEVICE WAS RETURNED TO OMSC FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PROBE BROKE OFF AT 11.5 MM FROM THE DISTAL END. THERE WAS NO SCRATCH, WHICH MAY LEAD TO THE FRACTURE, AROUND THE BROKEN POINT. THE SHAPE OF THE FRACTURE SURFACE SHOWED THAT A CRACK SPREAD FROM THE STARTING POINT OF THE FRACTURE. AND THERE WAS A COARSE PART ON THE FRACTURE SURFACE WHICH SHOWED THAT IT FRACTURED BY PHYSICAL STRESS. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. CONSIDERING THE EVALUATION RESULT OF THE SUBJECT DEVICE, OMSC CONCLUDED THAT THE PROBE BROKE DUE TO THE STRESS BY TOUCHING PHYSICALLY SOMETHING HAVING THE CRACKED PROBE. AS THE CAUSE OF THE CRACK ON THE PROBE, IT IS POSSIBLE THAT THE USER ACTIVATED THE ULTRASOUND OUTPUT APPLYING ONLY THE PROBE TIP TO THE TISSUE WITH STRONG FORCE OR TWISTING THE DEVICE WHILE GRASPING THE TISSUE. BASED UPON THE FINDING OF THE EVALUATION, THIS REPORT APPEARS TO BE RELATED TO USER HANDLING. THIS REPORT IS SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION. THIS REPORT IS ONE OF THE TWO REPORTS. CROSS REFERENCE MFR. REPORT # 8010047-2013-00504.

    Additional Manufacturer Narrative · 1

    OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC) PERFORMED A MDR RETROSPECTIVE REVIEW AND OMSC FOUND THAT THIS SUPPLEMENTAL REPORT IS REQUIRED. OMSC FOUND THERE WAS A WRITING ERROR IN CROSS-REFERENCE NUMBER FOR THE ASSOCIATED COMPLAINT. IT WAS ORIGINALLY STATED AS 8010047-2013-00504, BUT THE CORRECT IS 8010047-2014-00504.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OSMC) WAS INFORMED THAT DURING THE OPEN TOTAL GASTRECTOMY, ABNORMAL OUTPUT OCCURRED WITH THE SUBJECT DEVICE (THE FIRST DEVICE). AND THEN, THE PROBE OF THE DEVICE BROKE WHEN THE USER TOUCHED AND INSPECTED IT OUTSIDE THE BODY OF PATIENT. ALTHOUGH THE PHYSICIAN REPLACED IT WITH ANOTHER T3905 (THE SECOND DEVICE) AND CONTINUED THE PROCEDURE, ABNORMAL OUTPUT OCCURRED AGAIN, AND THE PROBE BROKE WHEN THE USER TOUCHED AND INSPECTED IT OUTSIDE THE BODY OF PATIENT WAS WELL. THE PHYSICIAN REPLACED THE SECOND DEVICE WITH THE THIRD ONE. THE PROCEDURE WAS COMPLETED. BOTH OF THE FIRST AND THE SECOND DEVICES WERE USED TWO TIMES. THERE WAS NO REPORT OF PATIENT'S INJURY REGARDING THIS EVENT. THIS MDR IS REGARDING THE FIRST BROKEN DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545741 SONOSURG SCISSORS 5 MM O.D., HF SERIES SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORPORATION T3925 NA

    Patients

    Seq Age Sex Outcome Treatment
    1