MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0545FCS

Device Problems Break (1069); Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

The suspect device was sent to olympus for evaluation.Inspection and testing found the tissue pad in the grasping section was also peeled off at the tip and the metal part of the grasping section was visible through the tissue pad.The tissue pad was torn without a missing part.Inspection and testing did not confirm that the probe was broken as described by the customer.In addition, there were marks on the probe and non-insulated area of the grasping section where they came in contact and were abraded.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The customer reported the intra-operative branch broke off inside the patient at the beginning of a laparoscopic sigmoid procedure.The fragment was retrieved laparoscopically.The procedure was completed using another similar device after a delay of approximately five minutes.There was no effect on the patient due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to e4, h6 and h10.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 tissue pad was worn away because no tissue was being grasped between the grasping section and the probe tip when the device was activated output in seal & cut mode for/after a transection of tissue.2) the tissue pad was excessively heated due to friction between the grasping section and the probe tip.This caused the tissue pad to be partially peeled away.The following information is included in the instructions for use (ifu): ¿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 the performance of this device.

• Brand Name: THUNDERBEAT 5 MM, 45 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: 16043330
• MDR Text Key: 308551772
• Report Number: 9614641-2022-00854
• 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,Followup
• Report Date: 01/25/2023

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-0545FCS
• Device Lot Number: KR178565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 12/28/2022
• Supplement Dates FDA Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2021
• 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