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

Model Number	TB-0009OFX
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the thunderbeat open fine jaw's tissue pad kept coming off several times during a therapeutic thyroid procedure.There was no internal shedding of the device.There were no reports of patient harm and the intended procedure was able to be successfully completed using a similar device.
Additional Manufacturer Narrative
To date, the device has not been returned.The user facility was contacted to obtain additional information and to check the status of the subject device.Should additional relevant information become available, a supplemental report will be submitted.E1/establishment name: tokiwakai tokiwa hospital public interest incorporated foundation (added due to character limitation in respective field).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Correction to d4 and g2 (inadvertently selected healthcare professional).The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The tissue pad in the grasping section was worn and partially peeled off.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 peeling of the tissue pad occurred by the following mechanism(s).1) at the time of seal and cut output, the tissue pad was worn out because there was no grip between the gripping part and the probe tip (including after the tissue was cut).2) a part of the tissue pad peeled off due to abnormal heat generation due to friction between the gripping part and the probe tip.The event can be detected/prevented by following the instructions for use which state: "do not close the gripping part and seal and cut output when there is no grasping between the gripping part and the probe tip, or when it is not possible to confirm whether the living tissue or blood vessel being grasped has been incised.Due to abnormal heat generation caused by friction between the gripping part and the probe tip, the gripping part and the probe tip may be damaged, deformed, or falling off, and part of the tissue pad may peel off, leading to severe wear.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 treating living tissue or blood vessels in seal-and-cut mode, make an incision with light tension so that the incision can be seen.Also, when it is cut off, stop the output immediately.Otherwise, abnormal heat generation due to friction between the tissue pad and the probe tip may lead to damage, deformation, or disconnection of the gripping part (both the stainless-steel part and the fluoropolymer part) and the probe tip, or a part of the tissue pad may peel off.When cutting and 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 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.

• Brand Name: THUNDERBEAT OPEN FINE JAW TYPE X
• 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: 18826611
• Report Number: 9614641-2024-00552
• Device Sequence Number: 7935385
• Product Code: GEI
• UDI-Device Identifier: 04953170435829
• UDI-Public: 04953170435829
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TB-0009OFX
• Device Lot Number: 3XK30
• 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: 02/27/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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
• Patient Sex: Unknown