BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP

    MDR report key: 6183496 · Received December 16, 2016

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    Report

    Report Number
    2951238-2016-00953
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 4, 2016
    Report Date
    February 8, 2017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    PK111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS AMERICA FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AT THIS TIME; HOWEVER, THIS TYPE OF PROBE DAMAGE IS MOST LIKELY DUE TO THE OPERATOR'S TECHNIQUE. THE INSTRUCTION MANUAL CONTAINS SEVERAL WARNING STATEMENTS IN AN EFFORT TO PREVENT PROBE DAMAGE. "DO NOT TO ACTIVATE OUTPUT IN SEAL AND CUT MODE WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE OR VESSEL. DO NOT ACTIVATE OUTPUT WHILE APPLYING THE PROBE TIP TO THE TISSUE WITH A STRONG FORCE. DO NOT ACTIVATE OUTPUT WHILE GRASPING THICK AND HARD TISSUES. OTHERWISE, VARIOUS FORMS OF DAMAGE IN THE PROBE TIP AND/OR THE TISSUE PAD SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, EXPOSURE OF METAL, AND/OR FALLING INSIDE THE BODY CAVITY, AND/OR PARTIAL SEPARATING MAY OCCUR.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE DEVICE WAS TESTED USING OLYMPUS TEST EQUIPMENT; DEVICE WAS TESTED ON AS RECEIVED CONDITION, REVEALED TISSUE BUILD UP ON THE DEVICE. THE TEFLON PAD HAD NORMAL WEAR, NO METAL EXPOSURE. PROBE CHECK COULD NOT BE PERFORMED DUE TO BROKEN PROBE UNIT. ERROR CODE U509 WAS OBSERVED. THE DISTAL END WAS INSPECTED UNDER A MICROSCOPE AND FOUND APPROXIMATELY 14MM OF THE PROBE UNIT IS DETACHED /MISSING; MISSING PORTION OF THE PROBE UNIT WAS NOT RETURNED. IN ADDITION, CHARRED MARKS AND INDENTATION MARKS OF THE JAW WAS FOUND ON THE PROBE UNIT.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING BARIATRIC SURGERY THE PROBE BROKE OFF INSIDE THE PATIENT. THE BROKEN PART WAS RETRIEVED SUCCESSFULLY USING GRASPER. THE PROCEDURE WAS COMPLETED USING A DIFFERENT THUNDERBEAT DEVICE. FURTHERMORE, OLYMPUS WAS INFORMED THAT METAL WAS EXPOSED ON THE JAW; HOWEVER THERE WAS NO DAMAGE TO THE TEFLON PAD. THE EVENT OCCURRED WHILE THE DOCTOR WAS CUTTING TISSUE WITH THE DEVICE. A ¿PROBE DAMAGE ¿ERROR WAS DISPLAYED ON THE GENERATOR DURING THE PROCEDURE. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED. THE DEVICE WAS INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE OBSERVED. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834060 THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0545FC PW302647

    Patients

    Seq Age Sex Outcome Treatment
    1