MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0545FCS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is returned, and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection and testing, it was observed that probe is broken off at 16.8 mm from the distal end site.The broken piece of the probe tip was not returned.Since the breakage is at the proximal end site, it is not possible to check if there any contact mark on inner site surface of the probe.The device h-electrode has coating peeled and scratched.The tissue pad has minor deformation.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.
Event or Problem Description
As reported for this event by the customer, during an unknown procedure, the device jaw broke off into the patient abdomen.The broken piece was retrieved from the patient body.There is no harm or adverse impact to the patient.
Additional Manufacturer Narrative
Additional information has been received for this event from the customer.There is more information on the device evaluation this supplemental report is being submitted to provide this information.Please see the updates in sections: b5, g3, g6, h2, h4, h6, and h10.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 at inspection.The breakage of the probe started at the cracked area of the probe.Also, black discoloration of the area near the starting point of the breakage was observed.No scratches or contact marks on the non-insulated area of the grasping section were observed.The exact cause of the breakage of the probe could not be determined.However, based on device evaluation and the results of investigation in the past, a likely mechanism causing the breakage of the probe might be the following: during the output activation in seal and cut mode, the distal end of the probe was slightly contacting a device with a thin tip, causing spark generation.A force was applied to the probe during spark generation.A force to grasp tissue or a force to activate the output in seal and cut mode was applied to the probe.This generated cracks on the probe.Due to continuous use of the device, the cracks on the probe progressed.This led to breakage of the probe.The instructions for use includes the following statements that warn against the issue: 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.
Event or Problem Description
Addendum (b)(6) 2022: the broken piece was removed from the patient with laparoscopic forceps.The procedure was therapeutic lift colostomy with laparoscopy.Event occurred during the middle of the procedure.The functional mode and settings at the time of the event are not known.The procedure was completed with approximately two minutes delay required to switch to a new similar device.The delay was not clinically relevant.It is not known if the patient needed additional anesthesia.The device was inspected prior to use with no anomaly noted.

• Brand Name: THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S
• 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: 15995366
• Report Number: 9614641-2022-00777
• Device Sequence Number: 6209116
• Product Code: GEI
• UDI-Device Identifier: 14953170383516
• UDI-Public: 04953170383519
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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 Expiration Date: 02/14/2025
• Device Model Number: TB-0545FCS
• Device Lot Number: KR206280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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