BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT OPEN FINE JAW

    MDR report key: 6521606 · Received April 26, 2017

    Report

    Report Number
    8010047-2017-00504
    Event Type
    Malfunction
    Date Received
    April 26, 2017
    Date of Event
    March 24, 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 OMSC FOR EVALUATION OMSC CONFIRMED THAT THE INSERTION SECTION AROUND THE PROBE WAS DEFORMED. THE COATING OF INSERTION SECTION AROUND THE PROBE WAS PARTIALLY MISSING. THE MANUFACTURING HISTORY WAS REVIEWED, WITH NO IRREGULARITIES NOTED. THESE TYPES OF THE COATING DAMAGE AND DEFORMATION OF THE INSERTION SECTION ARE MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE. THE DEFORMATION OF THE INSERTION SECTION IS LIKELY TO BE CAUSED BY AN EXCESSIVE FORCE APPLIED ON THE INSERTION SECTION. THE INSERTION SECTION WAS DEFORMED FURTHER AND THE COATING MIGHT BE MISSING WHEN THE USER SQUEEZED THE HANDLE WITH THE DEFORMED INSERTION SECTION, WHICH CAUSED CONTACTING BETWEEN THE INSERTION SECTION AND THE GRASPING SECTION. 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 AN UNSPECIFIED PROCEDURE, THE SUBJECT DEVICE WAS USED. IN THE PROCEDURE, THE INSERTION SECTION AROUND THE PROBE WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER THUNDERBEAT. THERE WAS NO PATIENT INJURY REPORTED. OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED AND EVALUATED THE SUBJECT DEVICE. AS THE RESULT, OMSC CONFIRMED THAT THE COATING OF GRASPING SECTION WAS PARTIALLY MISSING ON APRIL 6, 2017. AND IT WAS NOT REPORTED THAT THE FRAGMENT OF THE COATING FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305746 THUNDERBEAT OPEN FINE JAW ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0009OF 71K

    Patients

    Seq Age Sex Outcome Treatment
    1