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

Model Number	TB-0009OF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Full name of the facility is local independent administrative institution saitama prefectural hospital organization saitama cancer center.The device is returned, and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection and testing, it was observed that the probe was broken at 17 mm from the tip of the probe.There were traces of contact with non-insulated parts around the fractured part.When the probe fracture surface was checked, fracture was starting from the contact mark.There was a trace of contact with the tip of the probe on the non-insulated part.The tissue pad was worn.The coating on the grip was peeling off.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, in the middle of a therapeutic orthopedic procedure, the device probe broke off at the base.The broken piece was recovered.Error message u504 probe damage was received for the device.Procedure was completed with a new device of the same model number with a delay.The patient did not need additional anesthesia.There is no harm or adverse impact to the patient.Total operating time of the procedure is between two to five hours.The intelligent tissue monitoring (itm) setting was on during the procedure.Settings at the time of the event were seal and cut 1, seal 1.The device was inspected prior to use with no anomaly noted.The connections to the generator were checked.The transducer cords and other medical device cords were not bundled together.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on 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.Although a definitive root cause cannot be identified, the following step-by-step scenario likely caused the event: 1.The output was activated in seal & cut mode while the grasping section was grasping thick tissue.Therefore, the probe and the tissue pad came into contact at the rear end of the grasping section, causing the tissue pad to wear out.2.The non-insulated area of the grasping section and the probe came into contact due to wear of the tissue pad.3.The output in seal & cut was activated while the non-insulated area of the grasping section was in contact with the probe.As a result, a contact mark developed.4.A force to activate the output in seal &cut mode or a force to grasp tissue was applied to the probe.Therefore, cracks developed at a contact mark causing a probe damage error.(error code: u504) 5.A force was applied to the probe causing it to break.The following information is included in the instructions for use (ifu): ¿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.¿ ¿do not activate output while grasping thick, harder tissue, such as the stomach wall, with the distal part of the probe tip.Otherwise, the grasping section (tissue pad) may be worn out partially.Continued use under this condition may result in exposure of the metal area of the grasping section and a scratch on the probe tip.This could lead the probe tip to breaking and falling off into the body cavity during the output.¿ ¿if the grasping section, metal-exposed area around it or the probe tip gets stuck to tissue during treatment, wipe it with a soft object such as a piece of gauze or a brush.Do not attempt to scrape it with a sharp object such as a scalpel or the tip of tweezers.Otherwise, the grasping section, metal-exposed area around it, the fluorine resin part, a coated surface or the probe tip may be scratched and damaged, which may lead to fall-off of the damaged part into the body cavity or burns of the tissue by a high-frequency leak current output due to destruction of the insulation structure.¿ olympus will continue to monitor the performance of this device.

• Brand Name: THUNDERBEAT OPEN FINE JAW
• 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: 16575396
• Report Number: 9614641-2023-00396
• Device Sequence Number: 5967627
• Product Code: GEI
• UDI-Device Identifier: 04953170343346
• UDI-Public: 04953170343346
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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 Model Number: TB-0009OF
• Device Lot Number: 25K 20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: USG-400ESG-400
• Patient Sex: Unknown