MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT OPEN EXTENDED JAW; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0920OE
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported to olympus that during an open therapeutic radical prostatectomy procedure, the thunderbeat jaw broke off inside a patient.A new device was opened, and procedure was completed using a similar device.No report of any additional medical intervention/treatment required.The procedure was completed as planned with a 10-minute delay.No patient injury reported.The device was inspected before use.Details of the patient's current condition, device retrieval, medical intervention were requested but not available at the time of the report.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the probe was confirmed to be broken.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, the broken probe likely occurred due to the following mechanism: 1.Seal & cut¿ output was activated while grasping thick tissue with the tip of the grasping section.The proximal side of the tissue pad came in contact with the probe.As a result, the pad was worn away.2.The tissue pad wore away, causing the non-insulated of the grasping section to touch the probe.3.¿seal & cut¿ output was activated under this situation.The scratches indicated that the probe and grasping section were in contact with each other.4.The output was continuously activated in state of above description 3, and a force was applied to the probe, causing the probe to crack.5.A load was applied to the probe, causing it to break.However, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) 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 ptfe pad, such as premature wear, breakage, deformation, and/or falling off inside the body cavity and/or partial separating.¿ ¿when cutting or vessel sealing is performed in seal & cut mode, apply light tension on the tissue so that users can confirm that they are transected.Also, stop activation immediately after tissue is transected.Otherwise, the grasping section, the ptfe pad, or the probe tip may break and fall off, and partial separating of the ptfe pad may occur due to a local increase of temperature caused by the friction between ptfe pad and the probe tip during activation.¿ ¿do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue, or positioning the tissue, or twisting the shaft, or rotating the rotation knob.Manipulate and isolate the targeted tissue with another instrument, grasp the targeted tissue with the thunderbeat instrument, and then activate.Otherwise, it may cause the deforming/splitting/protruding of tissue pad or a scratch on the probe tip by interference with the other parts, which could result in the probe tip breaking and falling off inside the body cavity.¿ this supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.An update has been made to d9 and h3.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT OPEN EXTENDED JAW
• 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: 18457431
• Report Number: 9614641-2024-00030
• Device Sequence Number: 11555016
• Product Code: GEI
• UDI-Device Identifier: 04953170343315
• UDI-Public: 04953170343315
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K211838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2024

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-0920OE
• Device Lot Number: 34K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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: Male