An olympus employee reported on behalf of a customer, during preparation for use, the thunderbeat tip core needle broke and fell outside the patient¿s body.The therapeutic laparoscopic surgery was completed without delay, using a replacement device.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.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 likely that the probe broke due to contact with a surgical instrument or the non-insulated area of grasping section.Although a definitive root cause cannot be identified, the following step-by-step scenario likely caused the event: 1.Hard tissue, a metal object or a surgical instrument had been in contact with the probe during the output activation in seal & cut mode causing the scratches on the probe.2.The device was activated in seal &cut mode or while the grasping section was grasping tissue.This applied a force to the scratched area of the grasping section, causing this area to have cracks.3.A force was applied to the probe causing it to break.Or 1.Grasping section was closed without grasping anything while the device was activating in seal & cut mode (this includes after tissue resection) causing the tissue pad to wear out.2.Since the tissue pad was worn out, non-insulated area of the grasping section and the distal end of the probe came into contact.3.The output was activated in seal & cut mode in state of description stated above.Therefore, scratches (contact marks) were made on the distal end of the probe and the grasping section, indicating that they came into contact with each other.4.The device was activated in seal &cut mode or while the grasping section was grasping tissue.This applied a force to the scratched area of the grasping section, causing this area to have cracks.5.A force was applied to the probe causing it to break.The 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.¿ ¿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 the performance of this device.
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