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

Model Number	TB-0009OF
Medical Device Problem Codes	Degraded (1153); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturer date: the device was manufactured in july 2022 based on the three-digit lot information.The exact date could not be determined with only the three-digit lot number.During inspection and testing, the tissue pad was worn out and partially peeled off.A review of the device history record found no deviations that could have caused or contributed to the tissue pad peeling.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the tissue pad was peeling because the grasping section was closed without grasping anything while output activation in seal and cut mode was activated, including after tissue resection, causing the tissue pad to wear out and peel off partially.Due to wear of the tissue pad, the non-insulated area of the grasping section came into contact with the probe.The output was then activated while the non-insulated area of the grasping section was contacting the probe causing an ultrasonic level error and a contact mark was generated.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "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." olympus will continue to monitor field performance for this device.The reported issue (error code) was not confirmed during testing.There were contact marks on the probe and non-insulated area indicating they came in contact.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.
Event or Problem Description
The customer reported that the probe on the subject device was damaged during a thyroidectomy procedure.Error message u509 (ultrasonic level error) occurred after several rounds of sealing had been done by the surgeon.The procedure was completed using a similar device from another manufacturer.The subject device was sent to olympus for evaluation.During inspection and testing, the tissue pad was worn out and partially peeled off.This report is being submitted for the malfunction found during evaluation (tissue pad peeling).There was no effect on the patient due to the event.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15952826
• Report Number: 9614641-2022-00744
• Device Sequence Number: 7341430
• Product Code: GEI
• UDI-Device Identifier: 14953170343343
• UDI-Public: 04953170343346
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K211838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/09/2022

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: 21K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• 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: 09/15/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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