A customer reported to olympus, when cutting soft tissue, the thunderbeat clamp began to show an error on the screen.After using the clamp again for cutting tissue, it showed an error, and the probe detached.The probe did not fall within the patient¿s body cavity.The myomectomy was completed by using a replacement device of the same model.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.Correction to e3.The manufacturing date is unknown because the lot number is a 3-digit lot.Therefore, the manufacturing date will be blank.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, it is possible that the breakage of the probe occurred due to contact with other equipment or non-insulated parts as shown below.1.During output activation in seal & cut mode, the probe came into contact with hard tissue, metal or surgical instruments.This caused scratches on the probe.2.A force to activate the output in seal & cut mode, or a force to grasp the body tissue was applied to the probe.Therefore, cracks were branching from the scratches on the probe.Also, an error occurred.3.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.The thunderbeat instrument should be used for soft tissue.Do not activate output while grasping hard tissue such as bone or highly calcified tissue, or hard objects such as metal clips, stapler, other instruments, or forceps, and others.Otherwise, it may cause the probe tip to be scratched or come into direct contact with the metal area of the grasping section as the heat generated by the friction between the hard object and the probe tip could cause wear/deforming/split/protruding/partial separating of the tissue pad.In turn, the probe tip may break before displaying an error window or generating an alarm tone.Do not grasp or let the probe tip contact hard objects such as metal clips, stapler, or other instruments (e.G., uterine manipulator).Also, be careful to avoid contacting the probe tip with those accidentally.Particularly during activation, a scratch on the probe tip could occur due to ultrasonic vibration, which leads the probe tip to break and fall off into the body cavity.In addition, the high-frequency (rf bipolar) current flows through the metal and generates spark discharge, which may cause burns and decrease functionalities".Olympus will continue to monitor field performance for this device.
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