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

Model Number	TB-0009OFX
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported for this event by the customer, during an eventration procedure after five minutes f using the thunderbeat device, the device tip broke off.The procedure was completed with a new similar device.There is no consequence, harm or adverse impact to the patient.
Additional Manufacturer Narrative
The device has been returned but the device evaluation is not yet begun.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as any relevant new information becomes available.
Additional Manufacturer Narrative
The returned device has been evaluated.This supplemental report is being submitted to provide this information.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Upon evaluation of the device, it was observed that cracks had developed in the probe.The probe tip was not broken off.The customer reported event of the broken tip was not confirmed.However, an additional event of the rear end of the tissue pad being severely worn out and peeled was observed.There was a contact mark on the non-insulated of the grasping section indicating that the non-insulated area was in contact with the probe.There was a contact mark on the non-insulated of the grasping section indicating that the non-insulated area was in contact with the probe.A u510 ultrasonic error message was noted during testing.The exact cause of the peeling of the tissue pad and crack in the probe could not be exclusively identified.Based on the past investigation results, a likely cause of the phenomenon of the reported event might be the following: 1.The output was activated in seal and cut mode while the grasping section was grasping thick tissue.Therefore, the probe and the tissue pad came into contact at the rear end of the grasping section, causing the tissue pad to severely wear out.2.The non-insulated area of the grasping section and the probe came into contact due to wear of the tissue pad.3.The output in seal and cut was activated while the non-insulated area of the grasping section was in contact with the probe.As a result, a contact mark developed.4.A force to activate the output in seal and cut mode or a force to grasp tissue was applied to the probe.Therefore, cracks developed at a contact mark causing an error.The instructions for use includes the following statements that warn against the issue: ·do not activate output in seal and 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 and 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.¿ do not activate output while grasping thick, harder tissue, such as the stomach wall, with the distal part of the probe tip.Otherwise, the grasping section (tissue pad) may be worn out partially.Continued use under this condition may result in exposure of the metal area of the grasping section and a scratch on the probe tip.This could lead the probe tip to breaking and falling off into the body cavity during the output.

• 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: 16795583
• Report Number: 9614641-2023-00553
• Device Sequence Number: 14237953
• Product Code: GEI
• UDI-Device Identifier: 04953170394577
• UDI-Public: 04953170394577
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 2XK 26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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