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

Model Number	TB-0920OE
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned to olympus.However, an evaluation has not been completed at this time.The investigation is ongoing and the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
A customer reported to olympus that during an hysterectomy, one of two jaws broke off in the patient.The surgeon used another scissor to retrieve the missing piece and complete the procedure.There was a 20 minute delay reported and no patient injury confirmed.This report is being submitted for the event of one of two jaw breaking off in the patient, requiring a medical intervention of the surgeon needing to use a different device to retrieve the broken piece from inside the patient.Requests for additional information have been performed.No additional information is available at this time.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to a3 and d4 for information inadvertently left out.The device was returned and inspected.The customer's complaint was confirmed.The probe was broken at the proximal end.There was a mark in the probe which came in contact to the non-insulated area of grasping section and was abraded against it.There was a contact mark on the non-insulated area which indicates that the probe was contacting the non-insulated area.Also, wear of the tissue pad was observed.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, the exact cause could not be determined.However, a likely mechanism causing the broken probe might be the following: 1.Seal & cut¿ output was activated while grasping a thick tissue with the tip of the grasping section.The proximal side of the tissue pad come in contact to the probe.As a result, the pad was worn away.2.The tissue pad was worn away, causing the non-insulated of the grasping section to touch the probe.3.¿seal & cut¿ output was activated under this situation, the scratches indicating that the probe and grasping section were in contact with each other were made.4.The output was continuously activated in state of above description 3, and a force was applied to the probe, causing the probe cracked.5.A load was applied to the probe and it broke.The event can be prevented by following the instructions for use which state: ¿ "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 ptfe pad, such as premature wear, breakage, deformation, and/or falling off inside the body cavity and/or partial separating.¿ when cutting or 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 ptfe pad, or the probe tip may break and fall off, and partial separating of the ptfe pad may occur due to a local increase of temperature caused by the friction between ptfe pad and the probe tip during activation.¿ do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue, or positioning the tissue, or twisting the shaft, or rotating the rotation knob.Manipulate and isolate the targeted tissue with another instrument, grasp the targeted tissue with the thunderbeat instrument, and then activate.Otherwise, it may cause the deforming/splitting/protruding of tissue pad or a scratch on the probe tip by interference with the other parts, which could result in the probe tip breaking and falling off inside the body cavity." olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT OPEN EXTENDED 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: 16857444
• Report Number: 9614641-2023-00594
• Device Sequence Number: 14269116
• Product Code: GEI
• UDI-Device Identifier: 04953170343315
• UDI-Public: 04953170343315
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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-0920OE
• Device Lot Number: 2XK07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• 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: 04/02/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female