MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0535FCS

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  Injury  

Event Description

It was reported that during a therapeutic myomectomy procedure when the energy activation button on the thunderbeat was pressed, probe damage error was produced and the probe tip broke.The medical staff immediately removed the probe tip from the patient's abdominal cavity using a pair of forceps.There was no delay in the procedure and the procedure was completed with a similar device as the hospital staff had stock of the same model.The product was inspected before the procedure and there was no abnormality.No patient harm reported.

Manufacturer Narrative

The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

This report is being supplemented to provide to provide a correction to the previous reported manufacture date.The previous report listed the subject device was manufactured on june, 2022.However, the subject device was manufactured on june, 2023 based on the provided 3 digit lot information.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, to provide an update to fields (h3) and to provide additional information received through follow up (b5).The subject device was manufactured in june, 2022 based on the provided 3 digit lot information, but the specific date is unknown.The suspected device referenced in this report was returned to korean logistic site for disposal.A photo showing breakage of the tip was submitted.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, it is likely that the probe broke which led to recovery of the subject device occurred due to contact with other equipment or non-insulating parts.1.Grasping section was closed without grasping anything while the device was activating in seal & cut mode (this includes after tissue resection) causing the tissue pad to wear out.2.Since the tissue pad was worn out, non-insulated area of the grasping section and the distal end of the probe came into contact.3.The output was activated in seal & cut mode in state of description stated above.Therefore, scratches (contact marks) were made on the distal end of the probe and the grasping section, indicating that they came into contact with each other.4.The device was activated in seal &cut mode or while the grasping section was grasping tissue.This applied a force to the scratched area of the grasping section, causing this area to have cracks also, probe damage error occurred.( error code: u504) 5.A force was applied to the probe causing it to break.1.During the output activation in seal & cut mode, the probe came into contact with hard tissue, metal objects or surgical instruments.This resulted in scratches.2.The device was activated in seal &cut mode or while the grasping section was grasping tissue.This applied a force to the scratched area of the grasping section, causing this area to have cracks also, probe damage error occurred.( error code: u504) 3.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 detected/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 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 it is 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." "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." "do not grasp or let the probe tip contact hard objects such as metal clips, stapler, or other instruments (e.G., uterine manipulator).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." olympus will continue to monitor field performance for this device.H3 other text : (okr) device was discarded at korean logistic site.

Event Description

It was reported that the patient did not experience any adverse effects or complication.There was no effect to the patent's current condition or patient's outcome due to the procedure.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
• Type of Device: 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: 19032511
• MDR Text Key: 339245049
• Report Number: 9614641-2024-00827
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383540
• UDI-Public: 04953170383540
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Device Lot Number: 36K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention