BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP

    MDR report key: 10282732 · Received July 16, 2020

    Report

    Report Number
    8010047-2020-04474
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    June 17, 2020
    Report Date
    October 9, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    PMA / PMN Number
    K111202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND AN EVALUATION WAS PERFORMED. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. PLEASE SEE THE UPDATES IN SECTIONS: D4 (LOT#). ACTUAL LOT#: F THE DEVICE IS NOT KR910813, BUT IS KR910680. MANUFACTURE DATE OF THE DEVICE IS NOT KNOWN. THE USER COMPLAINT WAS CONFIRMED. THE DEVICE WAS ATTACHED TO THE USG-400 / ESG-400 AND A PROBE CHECK WAS PERFORMED; THE DEVICE PASSED THE PROBE CHECK. BOTH SWITCHES WERE CHECKED AND FOUND BOTH SWITCHES ARE FUNCTIONAL. A VISUAL INSPECTION ON THE RECEIVED CONDITION WAS PERFORMED ON THE DEVICE; THERE IS SOME TISSUE BUILD UP. THE PTFE PAD (TEFLON PAD) WAS INSPECTED AND FOUND IT IS SEPARATED AND MISSING/DETACHED A PORTION EXPOSING METAL; THE DETACHED / MISSING PORTION TEFLON PAD WAS RETURNED. ADDITIONALLY, OBSERVED CHARRED MARKS ON THE TEFLON PAD. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND OBSERVED CHARRED MARKS ON THE PROBE UNIT. THE WIPER MOVEMENT IS NORMAL. THE CONSISTENCY OF MOVEMENT OF THE HANDLE AND JAW IS NORMAL. THE HANDLE LOAD IS NORMAL. THE ROTATION OF THE KNOB TORQUE IS NORMAL AND SMOOTH.

    Additional Manufacturer Narrative · 0

    THERE IS MORE INFORMATION ON THE DEVICE EVALUATION. DEVICE MANUFACTURE DATE IS NOT KNOWN. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. PLEASE SEE THE UPDATES IN SECTIONS: G4, G7, H2, H3, H6, AND H10. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THERE WERE NO ANOMALIES IN THE DEVICE MANUFACTURING. THE REPORTED ISSUE OF THE DEVICE IS TEFLON PAD SEPARATION WITH A PIECE DETACHED. THE USER COMPLAINT WAS CONFIRMED. THE DEVICE WAS ATTACHED TO THE USG-400/ESG-400 AND A PROBE CHECK WAS PERFORMED; THE DEVICE PASSED THE PROBE CHECK. BOTH SWITCHES WERE CHECKED AND FOUND BOTH SWITCHES ARE FUNCTIONAL. A VISUAL INSPECTION ON THE RECEIVED CONDITION WAS PERFORMED ON THE DEVICE; THERE IS SOME TISSUE BUILD UP. THE PTFE PAD (TEFLON PAD) WAS INSPECTED AND FOUND IT IS SEPARATED AND MISSING/DETACHED A PORTION EXPOSING METAL; THE DETACHED/MISSING PORTION TEFLON PAD WAS RETURNED. ADDITIONALLY, OBSERVED CHARRED MARKS ON THE TEFLON PAD. THE DISTAL END OF THE DEVICE WAS INSPECTED UNDER A MICROSCOPE AND OBSERVED CHARRED MARKS ON THE PROBE UNIT. THE WIPER MOVEMENT IS NORMAL. THE CONSISTENCY OF MOVEMENT OF THE HANDLE AND JAW IS NORMAL. THE HANDLE LOAD IS NORMAL. THE ROTATION OF THE KNOB TORQUE IS NORMAL AND SMOOTH. THE ROOT CAUSE OF THE ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER BASED ON THE PAST SIMILAR CASES, THE FALLING OF THE TISSUE PAD WAS LIKELY CAUSED BY THE FOLLOWING MECHANISM: ¿ THE DISTAL END OF THE TISSUE PAD WAS PEELED AWAY BECAUSE THE CUSTOMER PERFORMED OUTPUT WHILE GRASPING NOTHING (INCLUDING THE CASE THE USER KEPT ACTIVATING AFTER CUTTING TISSUE). THE INSTRUCTIONS FOR USE INCLUDES THE FOLLOWING STATEMENTS: ¿ DO NOT ACTIVATE OUTPUT IN SEAL & CUT MODE WHILE THE GRASPING SECTION IS CLOSED WITHOUT CONTACTING TISSUE OR VESSEL, OR ENSURING THAT TISSUE IS TRANSECTED. OTHERWISE, A LOCAL INCREASE OF THE TEMPERATURE DUE TO A FRICTION BETWEEN THE PROBE TIP AND THE GRASPING SECTION MAY RESULT IN VARIOUS FORMS OF DAMAGE IN THE PROBE TIP AND/OR THE TISSUE PAD, SUCH AS PREMATURE WEAR, BREAKAGE, DEFORMATION, AND/OR FALLING OFF INSIDE THE BODY CAVITY AND/OR PARTIAL SEPARATING. ¿ WHEN CUTTING AND VESSEL SEALING IS PERFORMED IN SEAL & CUT MODE, APPLY LIGHT TENSION ON THE TISSUE SO THAT USERS CAN CONFIRM IT IS TRANSECTED. ALSO, STOP ACTIVATION IMMEDIATELY AFTER TISSUE IS TRANSECTED. OTHERWISE, THE GRASPING SECTION, THE TISSUE PAD, OR THE PROBE TIP MAY BREAK AND FALL OFF, AND PARTIAL SEPARATING OF THE TISSUE PAD MAY OCCUR DUE TO A LOCAL INCREASE OF TEMPERATURE CAUSED BY THE FRICTION BETWEEN TISSUE PAD AND THE PROBE TIP DURING ACTIVATION.

    Additional Manufacturer Narrative · 1

    DUE DILIGENCE WAS EXECUTED FOR THIS EVENT. THE PATIENT¿S BMI IS 23.6. THE INITIAL REPORTER'S JOB TITLE IS DIRECTOR OF SURGICAL SERVICES. THE DEVICE IS NOT RETURNED, AS SUCH A DEFINITIVE ROOT CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED AT THIS TIME. SUPPLEMENTAL REPORT(S) WILL BE FILED AS THE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED FOR THIS EVENT, DURING THE END OF THE THERAPEUTIC LAPAROSCOPIC SALPINGECTOMY, THE TEFLON PAD PIECE FELL INTO THE PATIENT. THE TEFLON PAD OF THE DEVICE WAS MELTING AND THE METAL WAS EXPOSED ON THE JAW. THE PROCEDURE WAS DELAYED BY 10 MINUTES NEEDED TO RETRIEVED THE PIECE FROM THE PATIENT. THE PIECE WAS REMOVED BY USING A LAPAROSCOPIC GRASPER. THE PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WAS NO ADVERSE IMPACT TO THE PATIENT. THE PHYSICIAN IS TRAINED AND EXPERIENCED IN THE USE OF THE DEVICE. THE GENERATOR SETTINGS WERE 1, 3. THERE WERE NO ERROR CODES. THE DEVICE WAS INSPECTED PRIOR TO USE. THE CONNECTION POINTS TO THE GENERATOR WERE INSPECTED. THERE WAS NO CABLE DAMAGE OBSERVED. THE TRANSDUCER CORDS OR THE CORDS OF ANY OTHER MEDICAL DEVICE WERE NOT BUNDLED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750235 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FC KR910680

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR