BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONOSURG SCISSORS 5 MM O.D., HF SERIES

    MDR report key: 4951401 · Received July 29, 2015

    Report

    Report Number
    8010047-2015-00664
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 10, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE REPORTED DEVICE EVALUATION RESULT IN FOLLOW-UP #1. WE INFORM THIS TIME THAT THERE WAS THE FOLLOWING MISTAKE IN THIS DEVICE EVALUATION RESULT. WRONG: THE TIP OF THE GRASPING SURFACE WAS WORN OUT. CORRECT: THE TIP OF THE GRASPING SURFACE WAS NOT WORN OUT.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE DEVICE EVALUATION AND CORRECT EVALUATION CODES AS OLYMPUS MEDICAL SYSTEMS CORP. ACQUIRED THE PHOTOS OF THE SUBJECT DEVICE FOR EVALUATION. THE EVALUATION CONFIRMED THAT THE PROBE BROKE OFF AT 16-18MM FROM THE DISTAL END, AND THE TIP OF THE GRASPING SURFACE WAS WORN OUT. THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE WAS REVIEWED, WITH NO IRREGULARITIES THAT RELATED TO THIS PHENOMENON NOTED. AS THE RESULT OF SIMILAR PHENOMENON'S EVALUATION, WE HAVE CONCLUDED THAT THE PROBE BROKE BECAUSE PHYSICAL STRESS WAS APPLIED TO THE PROBE WHICH HAD ALREADY BEEN CRACKED. 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, PUSHING A PROBE AGAINST THE HARD TISSUE OR TWISTING THE DEVICE WHILE GRASPING THE TISSUE. IMPROPER HANDLING OF THE SUBJECT DEVICE CANNOT BE RULED OUT AS A CONTRIBUTORY FACTOR TO THIS EVENT. THE ABOVE HANDLING HAS ALREADY BEEN RESTRICTED ON THE INSTRUCTION MANUAL OF THE SUBJECT DEVICE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. FOR EVALUATION. THE MANUFACTURING HISTORY OF THE SUBJECT DEVICE WAS REVIEWED, WITH NO IRREGULARITIES NOTED. THEREFORE THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION OR THE DEVICE IS RECEIVED A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE SUBJECT DEVICE WAS USED DURING A PROCEDURE OF THYROIDAL RESECTION. WHEN THE USER RESECTED A TISSUE, THE PROBE OF THE SUBJECT DEVICE BROKE OFF INSIDE THE PATIENT'S BODY. THE FRAGMENT OF THE PROBE WAS RETRIEVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494689 SONOSURG SCISSORS 5 MM O.D., HF SERIES SONOSURG SCISSORS LFL OLYMPUS MEDICAL SYSTEMS CORP. T3925

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR