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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed that during the device evaluation, the ultrasonic surgical device exhibited partial separation of the tissue pad insulation.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of 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, a definitive root cause for the event could not be determined.However, it is likely that the cause of the phenomenon might be occurred due to the following: 1.The grasping section was closed without grasping anything while the output activation in seal & cut mode was activated, (this includes after tissue resection) causing the tissue pad to wear out and peel off partially.2.Due to wear of the tissue pad, the non-insulated area of the grasping section came into contact with the probe.3.The output was activated while the non-insulated area of the grasping section was contacting the probe causing an error.As a result, a contact mark developed.Content of the instruction manual was confirmed.The instruction manual contains the following descriptions, and it warns against this event.Drawing number and revision number of ifu: rc3907 05.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 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: 19568054
• Report Number: 9614641-2024-01287
• Device Sequence Number: 15197031
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2024

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: Other
• Device Model Number: TB-0009OFX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: USG-400 GENERATOR (SERIAL NO: (B)(6))
• Patient Sex: Unknown