BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5MM X 35CM, FRONT ACTUATED GRIP

    MDR report key: 5072499 · Received September 11, 2015

    Report

    Report Number
    2951238-2015-00422
    Event Type
    Malfunction
    Date Received
    September 11, 2015
    Date of Event
    June 24, 2015
    Report Date
    September 11, 2015
    Manufacturer
    OLYMPUS MEDICAL SYSTEM CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. THIS TYPE OF PROBE 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 PROBE. "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 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 SEPARATION MAY OCCUR." IF ADDITIONAL INFORMATION OR IF THE DEVICE IS RECEIVED AT A LATER TIME, THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A VOLUNTARY MEDWATCH NUMBER MW5043457 STATING THAT "WHILE USING THE OLYMPUS THUNDERBEAT HANDPIECE 5MM X 35CM (REF: TB-0535FC) (LOT MK942302), DURING A SURGICAL PROCEDURE, THE OSCILLATING TIP BROKE OFF IN THE PATIENT. THE ENTIRE TIP WAS RETRIEVED. DIAGNOSIS OR REASON FOR USE: USED DURING LAPAROSCOPIC PROCEDURE." OLYMPUS FOLLOWED UP WITH THE USER FACILITY AND IT WAS REPORTED THAT DURING A THERAPEUTIC LAPAROSCOPIC SURGERY PROCEDURE, THE OSCILLATING TIP BROKE OFF INSIDE THE PATIENT. THE SURGEON USED A GRASPER AND SUCCESSFULLY RETRIEVED THE BROKEN PIECE. THE INTENDED PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602491 THUNDERBEAT 5MM X 35CM, FRONT ACTUATED GRIP ULTRASONIC SURGICAL SYSTEM GEI OLYMPUS MEDICAL SYSTEM CORPORATION TB-0535FC MK942302

    Patients

    Seq Age Sex Outcome Treatment
    1