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

Model Number	TB-0009OFX
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the evaluation found the probe was broken 20mm from the tip, scratches were found around the fracture, and the probe fracture surface had cracks starting from the scratches.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
It was reported, the thunderbeat probe broke when electricity was applied inside the patient's body during a therapeutic thyroidectomy.The parts fell into patient's head and neck and were retrieved with a forceps.The procedure was completed by replacing with a similar device.There was no reported patient impact.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out (g2).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 and past investigation results, a likely cause of the phenomenon of the reported event could be the following: 1) during the output activation in seal & cut mode, the probe was contacting hard tissue, metal objects or surgical instruments.2) scratches were generated on the probe.3) a force to activate the output in seal & cut mode, or a force to grasp the tissue was applied to the probe.Therefore, cracks were generated at the scratched area.4) a force was applied to the probe causing it to break.However, a specific root cause of the reported event could not be identified.The event can be prevented by following the instructions for use which state: "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." "during output, do not grasp or let the probe tip contact hard objects such as metal clips, stapler, or other instruments.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, which may lead to burns of the tissue by a high-frequency leak current output due to destruction of the insulation structure." 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: 18636631
• Report Number: 9614641-2024-00246
• Device Sequence Number: 20856172
• 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: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2024

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-0009OFX
• Device Lot Number: 37K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown