The device was returned to olympus for evaluation.The probe was broken at 10 mm from the distal end of the probe.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The event can be detected/prevented by following the instructions for use (ifu) which state: ·"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." based on the results of the investigation the exact cause of the event could not be determined.The likely mechanism causing the reported event could have been the following: 1.The tissue pad was worn out because the seal and cut was output with the gripper closed (including after the tissue was cut) without grasping the tissue.2.Since the tissue pad was worn out, non-insulated area of the grasping section and the distal end of the probe came into contact.3.The output was activated in seal & cut mode in state of description stated above.Therefore, scratches (contact marks) were made on the probe and the grasping section, indicating that they came into contact with each other.4.The device was activated in seal &cut mode or while the grasping section was grasping tissue.This applied a force to the scratched area of the grasping section, causing this area to have cracks.5.A force was applied to the probe causing it to break.Olympus will continue to monitor field performance for this device.
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