BEUDAMED
    FDA Adverse Event Death Summary report: N

    THUNDERBEAT OPEN EXTENDED JAW

    MDR report key: 6488894 · Received April 12, 2017

    Report

    Report Number
    2951238-2017-00232
    Event Type
    Death
    Date Received
    April 12, 2017
    Date of Event
    March 3, 2017
    Report Date
    July 10, 2017
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    PK132703
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE DEVICE EVALUATION RESULTS. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION COULD NOT DUPLICATE THE REPORTED ¿CHECK HANDPIECE¿ ERROR MESSAGE. A VISUAL INSPECTION WAS PERFORMED ON THE RECEIVED DEVICE AND FOUND THERE WAS SOME MINOR TISSUE BUILD UP. THE PTFE PAD (TEFLON PAD) WAS INSPECTED AND FOUND DAMAGED AND LIFTING AT THE PROXIMAL END EXPOSING METAL. A MICROSCOPIC INSPECTION WAS PERFORMED ON THE DISTAL END OF THE DEVICE AND FOUND THE PROBE UNIT CRACKED WITH CHAR MARKS. A U509 ERROR WAS OBSERVED ON THE TEST GENERATOR. THIS TYPE OF PROBE AND 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 PROBE AND TEFLON PAD. "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

    THERE WAS NO DEVICE RETURNED TO OLYMPUS FOR EVALUATION. THE CURRENT STATUS OF THE DEVICE IS UNKNOWN. THE CAUSE OF DEATH IS UNKNOWN. THE USER FACILITY DID NOT ALLEGE THE DEVICE TO BE THE CAUSE OF THE PATIENT¿S OUTCOME. THIS REPORT WILL BE UPDATED IF ADDITIONAL AND SIGNIFICANT INFORMATION BECOMES AVAILABLE LATER.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A TOTAL VAGINAL HYSTERECTOMY PROCEDURE TWO THUNDERBEAT HANDPIECES DISPLAYED THE FOLLOWING ERROR MESSAGES WHEN CONNECTED TO THE GENERATOR AND TRANSDUCER RESPECTIVELY: ¿REPLACE HANDPIECE¿ ERROR FOR THE FIRST HANDPIECE AND ¿CHECK HANDPIECE /CORD¿ ERROR ON THE SECOND HANDPIECE. THERE WAS NO DAMAGE TO THE TEFLON PAD AND NO DEVICE FRAGMENT FELL INSIDE PATIENT. THERE WAS MODERATE BLEEDING REPORTED AND WAS CONTROLLED USING AN UNSPECIFIED DEVICE. BOTH THE HANDPIECES WERE INSPECTED PRIOR TO USE AND NO ABNORMALITIES WERE FOUND. THE INTENDED PROCEDURE WAS COMPLETED USING AN UNSPECIFIED DEVICE. THERE WAS NO PATIENT INJURY REPORTED, BUT OLYMPUS WAS LATER INFORMED THAT THE PATIENT EXPIRED APPROXIMATELY 44 HOURS AFTER THE PROCEDURE. THIS IS REPORT 2 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270006 THUNDERBEAT OPEN EXTENDED JAW ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0920OE 67K

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death TB-0920OE / LOT NO. 67 K