This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was not returned; therefore, the reported phenomenon or condition of the device could not be confirmed.However, it is possible to infer the cause from the results of past similar investigations.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although a definitive root cause cannot be identified, the following step-by-step scenario likely caused the event: 1) 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.2) 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 & 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 the performance of this device.
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