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

Model Number TB-0009OFX

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

The device was returned and the evaluation found the tissue pad was worn and partially peeled off.The cover at the tip of the grip had come off.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during therapeutic thyroidectomy the tissue pad of the thunderbeat open fine jaw peeled off.There was no internal shedding of the device.A similar new device was replaced and the procedure was completed.The procedure was prolonged by 1 to 1.5 hours to replace with the new device.There were no health hazards reported to the patient.The device was inspected and there were no faults reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, to provide a correction to the initial with information inadvertently left out (b5), and to provide additional information received (b5), and to provide a correction to fields (b1 and h6-impact code).Correction to the initial supplemental report as based on the provided information this event is not considered a serious injury.However, this event will remain a product problem.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, a likely mechanism casing the tissue pad peeling might be the following: 1)during the output activation in seal & cut mode, nothing was grasped in between the grasping section and the distal end of the probe (this includes after tissue resection).Therefore, the tissue pad was worn out.2) due to friction between the grasping section and the distal end of the probe, abnormal heat was generated.This might have caused the tissue pad to partially peel off.Based on the results of replication testing, it is suggested that the distal cover became detached either during the procedure or during cleaning when other tools or equipment entered the gap between the non-insulated area and the distal cover.However, the specific circumstances of the occurrence could not be determined, and the root cause of the phenomenon could not be identified.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 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." "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." "during output, do not grasp or let the probe tip contact hard objects such as metal clips, stapler, or other instruments.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, which may lead to burns of the tissue by a high-frequency leak current output due to destruction of the insulation structure." olympus will continue to monitor field performance for this device.

Event Description

Additional information received: it was reported that it did not take 1 to 1.5 hours to replace the device; rather, the malfunction occurred about 1 to 1.5 hours into the procedure.The patient has been discharged from the hospital.No reports on hospital stay extended due to the device malfunction.No special medical intervention (i.E.Treatment outside the scope of the procedure) was required because of the reported problem.Information inadvertently left out: it was reported that the intelligent tissue monitoring (itm) was "off".The generator settings for were seal & cut 1 and seal 1.No delay in the procedure and no additional anesthesia required due to the device malfunction.The device and the connections to the generator were inspected prior to use.The transducer cords and other medical device cords (e.G.Electrocardiographs) are not tied together.

• Brand Name: THUNDERBEAT OPEN FINE JAW TYPE X
• 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: 18715216
• MDR Text Key: 335523992
• Report Number: 9614641-2024-00390
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0009OFX
• Device Lot Number: 38K29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2023
• 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
• Treatment: THUNDERBEAT TRANSDUCER TD-TB400 , SN-UNK; ULTRASONIC GENERATOR, USG-400, SN-UNK
• Patient Outcome(s): Other