A customer reported to olympus, the thunderbeat¿s probe bottom jaw came off.While in use, the generator began alarming and instructing to check probe.The device was removed from the patient and visually everything was fine.After troubleshooting per instructions, a visually examination of the probe for a second time and touching the jaw, the bottom portion fell off.The device fell outside of the patient¿s body.The subject device was changed, and the procedure continued.Three additional devices with the same lot number as the subject device were taken out of circulation.There was no report of patient harm associated with this event.
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This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Update to d9, h3, and h6 to account for device receipt and evaluation.The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.During the physical investigation, the following errors were detected: a visual inspection on the received condition was performed on the device.The probe was broken at 16,3 mm from the distal end of the probe.There were scratches around the broken area.The surface of the broken area was inspected.The probe was broken from the scratched area.The distal end of the item was inspected under a microscope and detected scratches or contact marks at the non-insulated area of the grasping section.The tissue pad was worn out.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the error and the probe broken possibly occurred by the following mechanism: 1.The output was activated in seal & cut mode while the grasping section was grasping thick tissue.Therefore, the probe and the tissue pad came into contact at the rear end of the grasping section, causing the tissue pad to wear out.2.The non-insulated area of the grasping section and the probe came into contact due to wear of the tissue pad.3.The output in seal & cut was activated while the non-insulated area of the grasping section was in contact with the probe.As a result, a contact mark developed.4.A force to activate the output in seal &cut mode or a force to grasp tissue was applied to the probe.Therefore, cracks developed at a contact mark causing the error.5.A force was applied to the probe causing it to break.The event can be detected/prevented by following the instructions for use 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.During the treatment, do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue, or twisting the handle.Also, do not insert the handle while the handle is twisted with respect to the tissue, do not grasp it, and do not activate the output.Otherwise, the probe tip and/or grasping section may be damaged, which may result in falling of the probe tip and/or tissue pad".Olympus will continue to monitor field performance for this device.
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