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 Degraded (1153); Material Split, Cut or Torn (4008)

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

Event Date 10/09/2022

Event Type  malfunction  

Event Description

The customer reported that the subject device suddenly stopped working during a laparoscopic colon procedure.The patient was not harmed and the procedure was continued with another similar device.The subject device was sent to olympus for evaluation.During inspection and testing, the tissue pad in the grasping section was worn and partially missing.This report is being submitted for the malfunction found during evaluation (missing tissue pad).

Manufacturer Narrative

During inspection and testing, the tissue pad in the grasping section was worn and partially missing.The metal part of the grasping section was visible through the tissue pad.The tissue pad in the grasping section was torn with a missing part.There were marks on the probe and non-insulated area of the grasping section where they came in contact and were abraded.A review of the device history record found no deviations that could have caused or contributed to the tissue pad damage.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the user's report of "stopped working" was due to an error.It is likely the error and missing tissue pad occurred because the grasping section was closed without grasping anything while the output in seal and cut mode was activated (this includes after tissue resection) causing the tissue pad to wear and be partially missing.The non-insulated area of the grasping section and the probe came into contact due to wear of the tissue pad.The output in seal & cut was activated while the non-insulated area of the grasping section was in contact with the probe.As a result, a contact mark was developed and it caused an error.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 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." "if the grasping section, metal-exposed area around it or the probe tip gets sticked tissue during treatment, wipe it with a soft object such as a piece of gauze or a brush.Do not attempt to scrape it with a sharp object such as a scalpel or the tip of tweezers.Otherwise, the grasping section, metal-exposed area around it, the fluorine resin part, a coated surface or the probe tip may be scratched and damaged, which may lead to fall-off of the damaged part into the body cavity or 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.The coating of the grasping section was partially peeled off due to being scraped with something hard and the coating of the probe was partially peeling likely due to the device being activated in seal and cut mode for a long duration while no tissue was grasped by the grasping section and the distal end of the probe (including activation continued after completion of tissue cutting).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.

• 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: 16042470
• MDR Text Key: 308548006
• Report Number: 9614641-2022-00852
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Other
• Type of Report: Initial
• Report Date: 12/23/2022

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
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Device Lot Number: KR912149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2020
• 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