BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT OPEN FINE JAW

    MDR report key: 6394282 · Received March 10, 2017

    Report

    Report Number
    8010047-2017-00278
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    November 14, 2016
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    PK151743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. AS A RESULT OF EVALUATION OF OMSC ON FEBRUARY 13, 2017, OMSC CONFIRMED THAT THE COATING ON THE OUTER SURFACE OF THE METAL SHEATH PARTIALLY CAME OFF. THE METAL SHEATH WAS DEFORMED AND CONTACTED WITH THE PROBE. THE COATING ADHERED TO THE GRASPING SECTION. THE SHORT CIRCUIT ERROR OCCURRED WHEN THE USER OUTPUT IN SEAL MODE WITH THE GRASPING SECTION CLOSED. THE MANUFACTURING RECORD WAS REVIEWED WITH NO IRREGULARITIES. THIS TYPE OF COATING DAMAGE IS MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE. BASED ON THE PAST SIMILAR CASES, IT WAS KNOWN THAT A LOAD WAS APPLIED TO THE METAL SHEATH, CAUSING THE METAL SHEATH TO BE DEFORMED AND CONTACTED WITH THE JAW. THE USER HELD THE CONTROL HANDLE ABOUT HALF WITH THE METAL SHEATH CONTACTED TO THE JAW. THE METAL SHEATH WAS FURTHER DEFORMED AND THE COATING PARTIALLY CAME OFF. THE COATING ADHERED TO THE GRASPING SECTION. THE SHOR CIRCUIT ERROR OCCURRED WHEN THE USER OUTPUT THE DEVICE IN SEAL & CUT MODE OR IN SEAL MODE WITH THE METAL SHEATH CONTACTING THE JAW. THE FOLLOWING DETAILS ARE FOUND IN THE INSTRUCTION MANUAL AS WARNING: SHOULD ANY IRREGULARITY (ERROR WINDOW, ABNORMAL NOISE, ABNORMAL OUTPUT, ABNORMAL OPERATION, ABNORMAL APPEARANCE, ETC.) OR MALFUNCTION BE OBSERVED WHILE USING THE THUNDERBEAT, STOP THE USE AND WITHDRAW THE INSTRUMENTS FROM THE BODY CAVITY. DO NOT WITHDRAW THE TRANSDUCER PLUG FROM THE ULTRASONIC GENERATOR. CHECK THE EQUIPMENT BY REFERRING TO CHAPTER 8, ¿TROUBLESHOOTING¿, IN THE INSTRUCTION MANUAL FOR THE ULTRASONIC GENERATOR. IF THE IRREGULARITY REMAINS AFTER TROUBLESHOOTING, REPLACE THE TRANSDUCER. IF THIS DOES NOT RESOLVE THE ISSUE, REPLACE THE THUNDERBEAT INSTRUMENT. IF THE IRREGULARITY REMAINS UNRESOLVED, CONTACT OLYMPUS; 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, A SHORT CIRCUIT ERROR OCCURRED. THE JAW AND THE METAL SHATH WERE IN CONTACT WITH THE PROBE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. FEBRUARY 13, 2017, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) CONFIRMED THAT THE COATING ON THE OUTER SURFACE OF THE METAL SHEATH PARTIALLY CAME OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176820 THUNDERBEAT OPEN FINE JAW ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0009OF 62K

    Patients

    Seq Age Sex Outcome Treatment
    1