MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0535FC
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1.Establishment name: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during a laparoscopic hysterectomy for multiple uterine leiomyomas, thunderbeat was used for tissue cutting.After using the product for more than half an hour, the tip of the ultrasonic knife fell off and this device was not able to be used to continue the procedure.Hence the medical staff ¿immediately¿ replaced a new device to continue with the surgery.The surgery time was reported to be extended, but the new device was ¿immediately¿ replaced by the staff indicating that the delay is expected to be minimal.Follow-up was conducted to request information if the device fell into the patient and if the device was removed from patient.Response received noted that the device piece did not fall into the body.At this time, there is no evidence that a life-threatening event occurred, that the patient developed permanent damage or impairment, or that additional medical/surgical intervention was done to prevent permanent damage or impairment that is associated with the use of an olympus device.
Event or Problem Description
Additional information received that the procedure was delayed by 30 minutes.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The subject device was manufactured in february 2023 based on the provided 3-digit lot information "32k".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 the probe damage error and the probe broken possibly occurred due to contact with a surgical instrument or the non-insulated area of grasping section.The detailed mechanisms are shown below.Mechanism 1: 1 during seal & cut output, the probe came into contact with hard tissues, metals or surgical equipment, resulting in scratches.2.The probe received an output load in seal & cut mode or a load applied when grasping tissue.As a result, the probe cracked from the scratch.3.The probe broke when added load.Mechanism 2: 1.The distal end of the tissue pad was worn away because ¿seal & cut¿ output was activated while grasping nothing (the user kept activating after cutting tissue).2.The tissue pad was worn out, causing the non-insulated of the grasping section to touch the probe.3.The ¿seal & cut¿ output was activated under this situation and the scratches indicated that the probe and grasping section were in contact with each other.However, the root cause of the reported event could not be identified.The event can be 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, or other instruments (e.G., uterine manipulator, 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/splitting/protruding/partial separating of the tissue pad.In turn, the probe 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.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
• Common Device Name: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20445834
• Report Number: 9614641-2024-01977
• Device Sequence Number: 20855669
• Product Code: GEI
• UDI-Device Identifier: 04953170337574
• UDI-Public: 04953170337574
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TB-0535FC
• Device Lot Number: 32K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown