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

Model Number TB-0535FC

Device Problem Degraded (1153)

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

Event Date 10/10/2022

Event Type  malfunction  

Event Description

The customer reported the coating burned off the tip of the subject device during an unspecified procedure.The customer opened another device and the coating burned off that device as well.A similar device from another manufacturer was used to complete the procedure.There was no harm or user injury reported due to the event.The subject device was sent to olympus for evaluation.During inspection and testing, the tissue pad was separated from the device and metal was exposed.This report is being submitted for the malfunction found during evaluation (tissue pad separation).This report is for the second device.The first device is being reported on the medwatch with patient identifier (b)(6) for a malfunction found during evaluation.

Manufacturer Narrative

During inspection and testing, the tissue pad was severely worn and separated from the device with metal exposed.A review of the device history record found no deviations that could have caused or contributed to the tissue pad separation.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the separation of the tissue pad occurred because nothing was grasped between the grasping section and the distal end of the probe while the output was activated in seal and cut mode (including after tissue resection).This caused the tissue pad to wear out severely.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." olympus will continue to monitor field performance for this device.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
• 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: 15973649
• MDR Text Key: 308535533
• Report Number: 9614641-2022-00758
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 14953170337571
• UDI-Public: 04953170337574
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TB-0535FC
• Device Lot Number: KR120093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2021
• 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