AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE
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Model Number TB-0535FCS |
Device Problem
Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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To date, the device has not been returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
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Event Description
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A customer reported to olympus, after an hour and half into a procedure, the thunderbeat displayed an u510 (ultrasonic frequency) error message on the generator.The staff followed the error message prompts, cleaned the jaw, and reconnected the transducer.At the late stage in the procedure, the surgeon did not want to replace the handpiece as only minor work was left to complete using an advanced energy device.When the surgeon tried to use the thunderbeat again, the probe portion of the jaw broke off and the handpiece could not be used.The probe did not break off inside of the patient.The therapeutic total laparoscopic hysterectomy was completed without delay.There was no report of patient harm associated with this event.
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Manufacturer Narrative
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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, the root cause could not be identified although it can be presumed that it was due to the tissue pad being worn and force was applied to the probe, causing it to break.The event can be detected/prevented in accordance with the warnings in the instructions for use: ·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 field performance for this device.
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