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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a therapeutic adrenal gland removal surgery the tissue pad of the thunderbeat fell off into the patient's body and was retrieved.The procedure was finished with another device.There was no reported patient impact.
Additional Manufacturer Narrative
E1/establishment name: tongji hospital affiliated to tongji medical college, huazhong university of science and technology added here due to character limitation in respective field.The subject device was manufactured on may 2023 based on the provided lot information, however an exact date is unknown (h4).The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
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 evaluated by olympus, and the customer¿s reported complaint (tissue pad fallen off) was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, the tissue pad likely fell off due to the following mechanism: 1.Part of the tissue pad peeled off because the seal & cut output was performed when nothing was gripped in the grip (including after the tissue was cut).2.The tissue pad fell off because a load was applied to the peeled off tissue pad.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 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.¿ this supplemental report includes additional information regarding the event.B5 has been updated accordingly.A correction has been made to g2 to provide information that was inadvertently not included in the initial medwatch.An update has been made to h3.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that the tissue pad fell off and into the patient¿s abdominal cavity.The tissue pad was retrieved within five minutes using forceps.The patient was under general anesthesia at the time of the event.The patient¿s outcome was reported as ¿normal.¿.

• 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: 19315200
• Report Number: 9614641-2024-01089
• Device Sequence Number: 3088455
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2024

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: 35K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• 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: 04/27/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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: Required Intervention
• Patient Sex: Unknown