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 Break (1069); Crack (1135)

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

Event Date 04/11/2023

Event Type  malfunction  

Manufacturer Narrative

E1: (b)(6).In addition to the cracked/broken probe, service found contact mark with the probe on the grasping section and contact mark with the grasping section on the probe.The tissue pad was damaged and the coating on the grasping section was coming off.Three attempts were made to obtain additional information regarding the reported event, but no response was received from the customer.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported that in the gynecology unit, an error message was observed five minutes after the device was used.The device then broke when cleaned with a soft damp cloth.The reported issue occurred during an unspecified procedure.There was no harm or user injury reported due to the event.The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, it was observed that the probe was cracked/ broken at 13.8 mm from the distal end site.This report is being submitted for the malfunction found during evaluation (cracked/broken probe).

Manufacturer Narrative

This report is being supplemented to provide additional information based on 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.Although a definitive root cause cannot be identified, the following step-by-step scenario likely caused the event: 1.The output was activated in seal & cut mode while the grasping section was grasping thick tissue.Therefore, the probe and the tissue pad came into contact at the rear end of the grasping section, causing the tissue pad to wear out.2.The non-insulated area of the grasping section and the probe came into contact due to wear of the tissue pad.3.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 developed.4.A force to activate the output in seal &cut mode or a force to grasp tissue was applied to the probe.Therefore, cracks developed at a contact mark causing the error.5.A force was applied to the probe causing it to break.The following is included in the instructions for use: "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.During the treatment, do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue, or twisting the handle.Also, do not insert the handle while the handle is twisted with respect to the tissue, do not grasp it, and do not activate the output.Otherwise, the probe tip and/or grasping section may be damaged, which may result in falling of the probe tip and/or tissue pad.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.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17791962
• MDR Text Key: 323968060
• Report Number: 9614641-2023-01361
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• 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: KR233484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2022
• 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