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 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, the tissue pad in the grasping section was worn away and part of the tissue pad was peeled away.The tissue pad was also torn with no part missing.The metal part of the grasping section was visible.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 tissue pad peeled because the tissue pad was worn away due to no tissue being grasped between the grasping section and the probe tip when output was activated in seal and cut mode for/after transection of tissue.As a result, the tissue pad was excessively heated due to friction between the grasping section and the probe tip which caused the tissue pad to be partially peeled away.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.In addition, the coating of the grasping section was partially peeled off due to dirt, such as a burn, being scraped off with something hard.Per the legal manufacturer, this device defect has no potential to cause or contribute to death or serious injury if the malfunction were to recur.

Event Description

The customer reported that, during a digestive exploratory laparoscopy procedure, the subject device was defective after four grips.The procedure was completed using a similar device.There was no effect on the patient due to the event.The subject device was sent to olympus for evaluation.During inspection and testing, the tissue pad in the grasping section was worn away and torn and part of the tissue pad was peeled away.This report is being submitted for the malfunction found during evaluation (partial loss of tissue pad).

• 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: 16018448
• MDR Text Key: 308488011
• Report Number: 9614641-2022-00813
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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: KR227540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• 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