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 Thermal Decomposition of Device (1071); Material Separation (1562)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that the teflon burned and slipped off part from probe on the electrosurgical system.This occurred during a therapeutic laparoscopic radical prostatectomy.There was no patient harm associated with the event.

Manufacturer Narrative

(b)(4) : [evaluation results].Evaluation date: 2024/3/11.Evaluator: (b)(4).Procedure purpose: therapeutic.Event: the first one alarm and when doctor pulled tb out teflon burned and slip off pae applicability judgment: pae(there is no any part of devices fall down in patient and patient condition still stable until completed the operation.).Investigation required: necessary.Tier classification: tier2.Universal failure code: ent0002(corrected from enp0005) (tissue pad falling /other failure mode).Containment measures: no (currently, no facts have been confirmed that suggest the possibility of the reported event expanding.).

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Correction: in g2, company representative is unchecked.Based on the results of the product inspection and investigation, it is inferred that the reported event likely happened because, during the seal and cut mode activation, there was nothing grasped between the grasping section and the probe's distal end, causing wear on the tissue pad.Friction between these parts likely generated abnormal heat, potentially leading to partial peeling of the tissue pad.The subject device was manufactured in december 2022 based on the provided 3-digit lot information, but a specific date could not be identified.Three attempts were performed to obtain additional information, but no response was received from the customer.The following is included in the instructions for use (ifu): the content of the instruction manual was reviewed, and the following description was found.This reported event was cautioned in the instruction manual.Drawing number and revision number of ifu: rc2994 12.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.Olympus will continue to monitor field performance for this device.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18906944
• MDR Text Key: 337698018
• Report Number: 9614641-2024-00665
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383557
• UDI-Public: 04953170383557
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K211838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Device Lot Number: 2ZK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: ESG-400- FOOT SWITCH; USG-400- ULTRASONIC GENERATOR