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Tw # (b)(4).Updated sections: b4,g3,g6,h2,h3,h6,h11.The device was returned to the factory for evaluation on 08/01/2025.Engineer evaluation follows: through evaluations conducted on the unit, electrical performance of the unit performed as expected.The investigation and discussions noted imply that the observations noted may have been due to use technique with the device.Details of the investigation conducted is noted as follows: investigation of device for function and visual abnormalities: visual inspection of the device for use: the harvesting tool was visually inspected for use and was noted to be covered with dried blood on the handle and black flex shaft of the unit, with blood and char noted on the jaws of the device, confirming it to have been used within the procedure.Visual inspection of the jaws and heater element of the tool: the device jaws were noted to be received with no evidence of damage, the jaws were closed with no gap in the opening.The silicone on the jaws were intact with no signs of damage, delamination, or peeling.The heater element of the unit was noted to be intact and properly attached to the jaws, with no outward flexing or bowing of the element from the jaws.Using the toggle, the jaws of the unit were actuated open ten times, and in each instance they opened acceptably and self-closed upon release of the toggle, consistent with expected normal performance.O visual inspection of the device flex shaft, handle, and cable the black flex shaft of the device was noted to show no signs of damage or being warped/bent, with the jaws of the device showing no signs of damage.The cable and connector were noted to show no signs of damage, with the connector pins observed to be intact and straight (not bent) within the connector.The toggle of the device appeared to have been not centered and slightly biased toward the back of the device.Electrical evaluation of the device: the harvesting tool was plugged into a hemopro 3 power supply and actuated using saline-soaked gauze between the jaws to check for the following: five (5) second continuous activation test: the device toggle was pulled back and held in the power delivery position for 5 seconds, checking the device for energy activation.The power supply provided the audible tone of continuous activation for the full 5 seconds, with steam being generated from the gauze where the jaws were located, showing active heat delivery.Following the 5 seconds, the toggle was released, and the device turned off.The above step was repeated 4 additional times (for total of 5 cycles), with placement of the jaws on a new, damp location on the gauze each time.The device was noted to show evidence of heat application (the power supply providing the audible tone for continuous activation, and steam being generated in the gauze) for each of the cycles.Full cycle continuous activation test: the device toggle was pulled back and held in the power delivery position for approximately 20 seconds, checking the device during this time for its cycle through the initial 5 seconds of continuous energy delivery, subsequent 10 seconds of pulse width modulation, along with the device's ability to shut off at 15 seconds.For the duration of the time the toggle was activated, the device was noted to deliver energy (steam generation from the gauze, with the power supply providing an audible tone of continuous energy for the first 5 seconds, and the expected tone for the subsequent 10 seconds of pulse width modulation).Following the 15 seconds of activation, while the toggle was continued to be pulled, the device shut off as per normal performance expectations.The toggle was continued to be held until approximately 20 seconds was achieved, and the device was noted to remain off.The performance of the device through the complete 20 second cycle showed normal performance, with energy delivery and the shutoff feature acting normally.The above step was repeated 2 additional times (for a total of 3 cycles), with placement of the jaws on a new, damp location on the gauze each time.The device was noted to perform the same each time, showing 5 seconds of continuous activation, 10 seconds of pulse width modulation, and shutting off at 15 seconds.Transection test with bacon: thawed bacon was placed within the full length of the device jaws, and then the toggle was activated.The device was noted to turn on and be able to cut through the bacon within a few seconds, showing the device to be able to transect through the bacon as per normal expected performance.The above step was repeated 4 additional times (for a total of 5 cycles), with a new piece of bacon being placed within the jaws each time.The device was noted to be capable to cut and cauterize the bacon each time.Device resistance and jaw heat up test: the harvesting tool was cleaned/decontaminated, and then using final test fixture mcv00112683 located within the complaints lab, the device was tested for resistance, and against the heat up test in accordance with final test procedure mcv00099135.The following was noted through the testing: resistance: the device was tested for resistance a total of 5 times, showing the following results (acceptance criteria: :51.20 ohm): data points collected: 0.8423, 0.8425, 0.8422, 0.8423, 0.8420 heat up test (acceptance criteria: displayed temperature on fixture must increase and turn 'green'/ displayed temperature must decrease once the toggle is released): the device was tested against the heat up test a total of 5 times, showing the following results: testing summary: pass.For each of the 5 cycles the device was tested, the device was noted to heat up and turn the displayed temperature to green (indicates proper heat ramp up), and, upon releasing the toggle of the device, the device was noted to deactivate.Evaluation of the device for total energy delivery: the harvesting tool was then tested twice for total energy delivery of the device, in accordance with test method mcv00110932.The testing of the device had shown it to provide the following (test acceptance criterion: (65j :;; x:;; 95j)): test 1 result: 72.105j test 2 result: 74.195j.Mechanical evaluation of the device jaws: using final test fixture mcv00112683 located within the complaints lab, the device was tested for jaw opening and closing forces in accordance with final test procedure mcv00099135.The following was noted through the testing: jaw opening force: the device was tested for jaw opening forces a total of 5 times, showing the following results (acceptance criteria: ;::: 0.16ibf): data points collected: 0.53, 0.66, 0.62, 0.62, 0.58 jaw closing force: the device was tested for jaw closing forces a total of 5 times, showing the following results (acceptance criteria: ;::: 1.151bf): data points collected: 1.36, 1.37, 1.38, 1.36, 1.36 in addition to the jaw force testing conducted above, the jaws of the device were cycled open and closed 200 times with gauze between the jaws of the device, while collecting jaw force data following the 50th, 100th, 150th , and 200th cycle of the device, to determine if the jaw forces were shifting lower as the device was continued through cycling.The following jaw forces were noted at each interval: following 50 cycles: jaw opening force: 0.66, 0.69, 0.60, 0.63, 0.70 jaw closing force: 1.38, 1.38, 1.39, 1.38, 1.38 following 100 cycles: jaw opening force: 0.64, 0.68, 0.69, 0.59, 0.68 jaw closing force: 1.37, 1.37, 1.38, 1.38, 1.37 following 150 cycles: jaw opening force: 0.61, 0.68, 0.58, 0.59, 0.53, jaw closing force: 1.38, 1.38, 1.39, 1.39, 1.37 following 200 cycles: jaw opening force: 0.61, 0.66, 0.58, 0.66, 0.63 jaw closing force: 1.38, 1.40, 1.41, 1.40, 1.41 based on the preliminary evaluation performed, both electrical and mechanical performance of the device show the device to be functioning normally and meeting specification criterion.In relation to the toggle positioning noted earlier, the handle of the complaint unit was opened to determine what may have caused the unit to show the backward bias.The following summarizes the review of the device in relation to a control unit: the handles of both units were then separated to look at the internal components which may have led to the toggle backward bias in comparison between the two units, most of the internal components appeared to be positioned similarly and with almost no anomalies noted.However, the one difference observed between the two units appeared to be the seating of the yoke rod in relation to the wire termination component.On the complaint unit, the yoke appeared to not be extended as far back past the wire termination as in the control unit.The toggle is connected to spring components which pull the toggle back to contact the wire termination and pull the wire termination/yoke components back to close the jaws of the device.With these mechanical interfaces in place, the positioning of the yoke and wire termination could potentially impact the neutral position of the toggle when not being pushed or pulled back.Hrough this investigation of the device, it is noted that while the toggle was noted to be biased back a little further visually, the jaws of the device were noted to function normally with jaw forces which were within specification limits.A review of the procedure and application of the device was performed through discussion with getinge personnel who were within the operating room during when the device was in use.A summary of the details noted with the procedure is noted below: the device, as returned, was noted to have a substantial buildup of char on the jaws of the device.The user of the device was stated to have historically used the hemopro 2 device, and, during prior procedures, would use the device with the microline (hemopro) power supply set to 3.5, and was therefore used to working at a quicker speed.In reference to use with the hemopro 2 system, per the hemopro 2 system ifu (ref mcv00112668 rev a), on page 2, there is a note which states, "when using the hemopro 2 evh system, always set the hemopro power supply level to setting 3.Use of settings other than 3 shall result in sub-optimal cutting and cauterizing." the user was noted by getinge personnel in attendance to have been in a rushed state, moving quickly through the procedure.Additionally, it was noted that at times during the procedure, the user would activate the jaws of the device around the vessel branch, but instead of waiting for the vessel to fall away from the harvesting tool jaws indicating a complete cauterization and cut, the user would prematurely push the jaws of the device forward, which would cause the vessel branches to break away from the jaws.The user was noted to have used the spot cautery feature of the device approximately 2-3 times to stop bleeding of the side branches.Post procedure following vessel extraction, when the vessel was prepared tested for leakage, the vessel branches were noted to show signs of leakage.Clips were used to close the side branches per standard practice by the user.Following completion of the procedure, a discussion with the user reminding them of the standard technique to allow the vessel branches to fall away from the jaws during cauterization and cutting and not push forward with the device prior to evidence of a complete cut.Based on the information provided, it would appear that the cautery deficiency noted by the vessel may have been primarily due to the user not waiting for the vessel to fall away from the jaw during the cauterizing and cutting step, with a secondary factor being char buildup on the jaws of the device.Per the hemopro 3 ifu (material specification mcv00111484 rev e): page 4, vessel harvesting section, note 2: apply energy to the harvesting tool by pulling the activation toggle back from the center position until a tactile click is felt and a stop is noticed.Cutting and cauterization is simultaneous within the jaws.When separation of the branch tissue is noticed, open the jaws and stop application of energy by pushing the activation toggle into the forward most position, and retract the harvesting tool slightly.Page 4, vessel harvesting section, caution statement between notes 3 and 4: caution: for optimum performance, keep jaw surfaces free of debris.Always use care when cleaning the harvesting tool.Mishandling of the unit may lead to inadvertent damage.Based on the review and the information gathered, the investigation of reported "failure to cut" appears to have been a result of user technique/error during the procedure and char buildup on the jaws on the device.Testing of the unit had shown appropriate electrical and mechanical performance, and investigations into the procedure had indicated that the user had not waited for the complete cutting and cauterizing of the vessel before advancing forward.In summary, the event noted of the vessel inadequate cautery appears to have been a result of use error with the device.The lot # 3000487726 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
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