BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT OPEN FINE JAW

    MDR report key: 6583763 · Received May 23, 2017

    Report

    Report Number
    8010047-2017-00623
    Event Type
    Malfunction
    Date Received
    May 23, 2017
    Date of Event
    April 13, 2017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    PK151743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THERE WAS A SCRATCH ON THE PROBE OF THE SUBJECT DEVICE. A PART OF THE COATING OF THE JAW WAS MISSING. AS THE RESULT OF CHECKING THE MANUFACTURING RECORD OF THE SAME LOT, THERE WAS NOTHING ABNORMAL FOUND. THIS TYPE OF THE COATING DAMAGE IS MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE. BASED ON THE EVALUATION AND SIMILAR CASES IN THE PAST, THE COATING OF THE JAW MIGHT BE MISSING SINCE THE FILTH ON THE JAW WAS WIPED WITH THE HARD OBJECT. ALSO, THE PROBE DAMAGE ERROR MIGHT BE OCCUR SINCE THE LOAD WAS APPLIED TO THE PROBE WHILE THE PROBE WAS COME IN CONTACT WITH THE HARD OBJECT AND THE SUBJECT DEVICE WAS ACTIVATED. THE INSTRUCTION MANUAL OF THE DEVICE HAS ALREADY WARNED AS FOLLOWS; DURING THE TREATMENT, DO NOT ACTIVATE OUTPUT WHILE APPLYING THE PROBE TIP TO THE TISSUE WITH A STRONG FORCE, GRASPING A THICK TISSUE, OR TWISTING THE HANDLE. ALSO, DO NOT GRASP THE TISSUE AND ACTIVATE THE OUTPUT WHILE THE HANDLE IS TWISTED. OTHERWISE, THE PROBE TIP AND/OR GRASPING SECTION MAY BE DAMAGED, WHICH MAY RESULT IN FALLING OF THE PROBE AND/OR GRASPING SECTION (TISSUE PAD).

    Description of Event or Problem · 1

    DURING A THYROIDECTOMY, THE PROBE DAMAGE ERROR OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. ON APRIL 28, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONFIRMED THAT THE COATING OF THE JAW WAS MISSING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365378 THUNDERBEAT OPEN FINE JAW ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0009OF 67K

    Patients

    Seq Age Sex Outcome Treatment
    1