BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S

    MDR report key: 12821997 · Received November 16, 2021

    Report

    Report Number
    8010047-2021-14611
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 29, 2021
    Report Date
    February 24, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    GEI
    UDI-DI
    04953170409677
    PMA / PMN Number
    K211838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE CUSTOMER. THIS SUPPLEMENTAL REPORT THE DOCTOR WAS TRAINED IN THE TECHNIQUES OF USING THE DEVICE. DOCTOR HAS FIVE YEARS EXPERIENCING OF USING THE DEVICE. THE PROCEDURAL TIPS AND TECHNIQUES INSTRUCTIONS THAT WERE DISTRIBUTED ON 09/27/2013 HAVE BEEN SHARED WITH THE USER FACILITY BY PHONE. THE BROKEN FRAGMENT DID NOT FALL INTO THE PATIENT. THE DOCTOR WAS PERFORMING CUT, WITH SETTINGS EFFECT 2 WITH ITM SETTING ON. THERE WAS A DELAY IN THE PROCEDURE OF APPROXIMATELY TWO TO FIVE MINUTES WHILE THE FAILED DEVICE WAS CHANGED FOR A NEW ONE. THERE WAS NO IMPACT TO THE OUTCOME OF PROCEDURE OR THE PATIENT. THE DEVICE IS TYPICALLY INSPECTED, INCLUDING THE CONNECTION POINTS TO THE GENERATOR, BEFORE USE AS PART OF THE PRE-OPERATION PROCEDURE. NO ANOMALIES WERE NOTED. THERE IS NO REPORT OF CABLE DAMAGE OR BUNDLING OF ANY MEDICAL DEVICE CORDS.

    Additional Manufacturer Narrative · 0

    DEVICE HAS BEEN RETURNED AND EVALUATED. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. ACTUAL DEVICE LOT NUMBER (#) IS KR151582; KR151209 IS PACKAGE LOT #. VISUAL INSPECTION OF AS RECEIVED CONDITION FOUND THAT TEFLON PAD IS WORN, SPLIT ON THE SIDE, LIFTED UP EXPOSING JAW METAL; HOWEVER, THE TEFLON PAD IS STILL ATTACHED TO THE JAW AND NOT MISSING. THERE ARE CHARRED MARKS ON THE GRASPING SECTION AND ON THE PROBE. THE PROBE COATING PARTIALLY MELTED AT DISTAL SECTION DUE TO THERMAL DAMAGE. THERE IS MINOR BIOMATERIAL ADHERED ON THE DISTAL SHAFT, BUT THE JAW GOLD INSULATION IS INTACT. 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 DEVICE WAS THEN ATTACHED TO THE ELECTROSURGICAL GENERATORS USG-400/ESG-400 AND A PROBE CHECK WAS PERFORMED; THE DEVICE PASSED THE PROBE CHECK AND GENERATED ENERGY OUTPUT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THAT THE TEFLON PAD WAS PEELING DUE TO THE FOLLOWING: THE TISSUE PAD WAS WORN AWAY BECAUSE NO TISSUE WAS BEING GRASPED BETWEEN THE GRASPING SECTION AND THE PROBE TIP WHEN THE DEVICE WAS ACTIVATED OUTPUT IN SEAL & CUT MODE FOR/AFTER A TRANSECTION OF TISSUE. THE TISSUE PAD WAS EXCESSIVELY HEATED DUE TO FRICTION BETWEEN THE GRASPING SECTION AND THE PROBE TIP. THIS CAUSED THE TISSUE PAD TO BE PARTIALLY PEELED AWAY. THIS FOLLOWING INFORMATION IS INCLUDED IN THE INSTRUCTIONS FOR USE (IFU): "DO NOT ACTIVATE OUTPUT IN SEAL AND 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 AND 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 · 0

    CORRECTION BEING MADE TO DEVICE LOT NUMBER. THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THIS INFORMATION. PLEASE SEE THE UPDATES IN SECTIONS: D4, G3, G6, H2, AND H10.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS NOT YET AVAILABLE FOR THIS EVENT. 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 · 0

    AS REPORTED FOR THIS EVENT, DURING A THERAPEUTIC LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE DEVICE TEFLON PAD CAME OFF AFTER LESS THAN 10 ACTIVATIONS. THE DEVICE WAS CHANGED FOR ANOTHER AND THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED AMOUNT OF EXTRA TIME REQUIRED. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718292 THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S ULTRASONIC SURGICAL DEVICE GEI OLYMPUS MEDICAL SYSTEMS CORP. TB-0535FCS KR151582 04953170409677

    Patients

    Seq Age Sex Outcome Treatment
    1 Female