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	04/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported during a therapeutic total bile resection surgery the probe of the thunderbeat fell off into the patient's body and was retrieved.The procedure was completed with a replacement device.There was no reported patient impact.
Event or Problem Description
It was reported that the broken device was very quickly retrieved with forceps.No additional interventions were required.
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 (via photo), and the customer¿s reported complaint (broken probe) 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 less than 1 year since the subject device was manufactured.Based on the results of the investigation, the broken probe was likely due to contacting other surgical instruments, or non-insulated areas as described in the mechanisms below.Mechanism #1 1.During output activation in seal & cut mode, the probe encountered hard tissue, metal, or surgical instruments.This caused scratches on the probe.2.A force to activate the output in seal & cut mode, or a force to grasp the body tissue was applied to the probe.Therefore, cracks were branching from the scratches on the probe.3.A force was applied to the probe causing it to break.Mechanism #2 1.Grasping section was closed without grasping anything while the device was activating in seal & cut mode (this includes after tissue resection) causing the tissue pad to wear out.2.Since the tissue pad was worn out, the non-insulated area of the grasping section and the distal end of the probe came into contact.3.The output was activated in seal & cut mode in the state of description stated above.This caused scratches (contact marks) on the distal end of the probe and the grasping section.The scratches indicate that the distal end of the probe was contacting the distal end of the grasping section.4.A force to activate the output in seal & cut mode, or a force to grasp the body tissue was applied to the probe.Therefore, cracks were branching from the scratches (contact marks) on the probe.5.A force was applied to the probe causing it to break.However, the root cause of the broken broke 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.¿ ¿the thunderbeat instrument should be used for soft tissue.Do not activate output while grasping hard tissue such as bone or highly calcified tissue, or hard objects such as metal clips, stapler, other instruments, or forceps, and others.Otherwise, it may cause the probe tip to be scratched or come into direct contact with the metal area of the grasping section as the heat generated by the friction between the hard object and the probe tip could cause wear/deforming/split/protruding/partial separating of the tissue pad.In turn, the probe tip may break before displaying an error window or generating an alarm tone.¿ ¿do not grasp or let the probe tip contact hard objects such as metal clips, stapler, or other instruments (e.G., uterine manipulator).Also, be careful to avoid contacting the probe tip with those accidentally.Particularly during activation, a scratch on the probe tip could occur due to ultrasonic vibration, which leads the probe tip to break and fall off into the body cavity.In addition, the high-frequency (rf bipolar) current flows through the metal and generates spark discharge, which may cause burns and decrease functionalities.¿ this supplemental report includes additional information regarding the event.Information has been added to b5.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.

• 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: 19250433
• Report Number: 9614641-2024-01038
• Device Sequence Number: 6397084
• 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): 05/28/2024

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: 38K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• 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: 04/21/2024
• Supplement Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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: ESG-400
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown