BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM, 35CM, FRONT-ACTUATED GRIP

    MDR report key: 5236842 · Received November 19, 2015

    Report

    Report Number
    2951238-2015-00559
    Event Type
    Malfunction
    Date Received
    November 19, 2015
    Date of Event
    November 2, 2015
    Report Date
    December 3, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO CORRECT THE LOT NUMBER AS MK951569, PROVIDE THE DEVICE MANUFACTURE DATE AS 7/10/15, AND PROVIDE THE INVESTIGATION RESULTS FOR THE DEVICE. THE DEVICE REFERENCED IN THIS REPORT WAS RETURNED TO OLYMPUS FOR EVALUATION. A PHYSICAL INSPECTION OF THE DEVICE FOUND THAT THE TEFLON PAD WAS SEPARATED FROM THE JAW EXPOSING METAL.

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT YET BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THIS TYPE OF TEFLON PAD DAMAGE IS MOST LIKELY RELATED TO THE OPERATOR'S TECHNIQUE. THE INSTRUCTION MANUAL CONTAINS SEVERAL WARNING STATEMENTS IN AN EFFORT TO PREVENT DAMAGE TO THE TEFLON PAD. "DO NOT 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 TISSUE. 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." IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE TEFLON PAD WAS DAMAGED. THE EXACT DAMAGE ON THE TEFLON PAD IS UNKNOWN AT THIS TIME. THERE WAS NO NOTE OF ANY DEVICE FRAGMENT FALLING INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768481 THUNDERBEAT 5MM, 35CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC MK951569

    Patients

    Seq Age Sex Outcome Treatment
    1