This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.As the device was not returned to olympus for inspection, the customer's allegation was not confirmed.Based on the results of the investigation, it is likely the following mechanisms led to the malfunction: 1)during the output activation in seal & cut mode, nothing was grasped in between the grasping section and the distal end of the probe (this includes after tissue resection).Therefore, the tissue pad was worn out.2) due to friction between the grasping section and the distal end of the probe, abnormal heat was generated.This might have caused the tissue pad to partially peel off.The event can be detected and prevented by following the instructions for use which state: drawing number and revision number of ifu: rc2994 12.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.Three attempts were performed to obtain additional information, but no response was received from the customer.Olympus will continue to monitor field performance for this device.
|