During inspection and testing, the tissue pad was severely worn and separated from the device with metal exposed.A review of the device history record found no deviations that could have caused or contributed to the tissue pad separation.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the separation of the tissue pad occurred because nothing was grasped between the grasping section and the distal end of the probe while the output was activated in seal and cut mode (including after tissue resection).This caused the tissue pad to wear out severely.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." olympus will continue to monitor field performance for this device.
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