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

Model Number	TB-0009OF
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	12/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that part of the upper jaw of the thunderbeat open fine jaw broke without any reason.The issue occurred during a therapeutic thyroidectomy procedure.The functional mode was seal and cut mode 1.The broken part was taken out by grasping it from the patient's body.The upper jaw contained the pad as well and they expected the pad was also damaged.The procedure was completed using a similar device.There was no reported patient harm or impact due to this event.
Additional Manufacturer Narrative
This mdr is being submitted as part of a retrospective review and remediation effort based on enhancements made to the company¿s mdr and complaint handling processes.Capas have been opened to manage the actions that are being taken to remediate this issue and ensure any required mdr reporting is completed.E1 establishment name: (b)(6) hospital.During device evaluation at olympus, it was found the complaint was confirmed and the non-insulated area of the grasping portion was partially detached.This event is under investigation.A supplemental report will be submitted upon receiving additional information.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct reportability decision to serious injury.Based on the provided picture, it was confirmed that the non-insulated area of the grasping portion detached partially.Based on the investigation results from similar complaints in the past, it is possible to infer its cause from the description.Therefore, it was decided that it was not necessary to perform an investigation by using a device with the same structure or a similar device.A review of the device history record found no abnormalities that relates to the reported event.The exact cause of the reported event could not be identified.However, based on the investigation results in the past, a likely mechanism causing the reported event might be the following: 1.The tissue was grasped at the distal end of the grasping portion, and the probe was in contact with the tissue pad at the rear end of the non-insulated area when the output was activated in seal & cut mode.2.The rear end of the tissue pad was worn out.This caused peeling of the rear end.3.The output was activated in seal & cut mode with the worn tissue pad.Therefore, the probe came into contact with the non-insulated area.This caused a contact mark on the probe and the non-insulated area.4.Since the output was activating when the rear end of the non-insulated area and the probe were contacting each other, the following force was applied to the non-insulated.As a result, the non-insulated area broke at the contact mark.1)ultrasonic vibration due to the output activation in seal & cut mode.2)heat was repeatedly applied to the non-insulated area due to ultrasonic vibration causing expansion/contraction of the non-insulated area.Content of the instruction manual was confirmed.The instruction manual contains the following descriptions, and it warns against this event.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.Olympus will continue to monitor field performance for 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: 17791981
• Report Number: 9614641-2023-01362
• Device Sequence Number: 18015014
• Product Code: GEI
• UDI-Device Identifier: 14953170343343
• UDI-Public: 04953170343346
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151743
• 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): 10/02/2023

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-0009OF
• Device Lot Number: 03K24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• 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: 12/22/2020
• Supplement Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2020
• 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