During inspection and testing, the tissue pad in the grasping section was worn away and a part of the tissue pad was peeled away.The tissue pad was torn with a missing part.There were also marks in the probe and the non-insulated area of the grasping section where they came in contact and were abraded.A review of the device history record found no deviations that could have caused or contributed to the tissue pad wear and peeling.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely intermittent cutting occurred due to an error.It is likely the error and peeling of the tissue pad occurred because the grasping section was closed without grasping anything while the output in seal and cut mode was activated, including after tissue resection, causing the tissue pad to wear and partially peel off.The non-insulated area of the grasping section and the probe came into contact due to wear of the tissue pad.The output in seal and cut mode was then activated while the non-insulated area of the grasping section was in contact with the probe.As a result, a contact mark was developed and an error was generated.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "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." "if the grasping section, metal-exposed area around it or the probe tip gets sticked tissue during treatment, wipe it with a soft object such as a piece of gauze or a brush.Do not attempt to scrape it with a sharp object such as a scalpel or the tip of tweezers.Otherwise, the grasping section, metal-exposed area around it, the fluorine resin part, a coated surface or the probe tip may be scratched and damaged, which may lead to fall-off of the damaged part into the body cavity or burns of the tissue by a high-frequency leak current output due to destruction of the insulation structure." olympus will continue to monitor field performance for this device.The coating of the grasping section was partially peeled off due to dirt, such as a burn, being scraped off with something hard, and the coating of the probe was partially peeling due to activation in seal and cut mode for a long duration while no tissue was grasped by the grasping section and the distal end of the probe, including after tissue cutting was completed.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.
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