MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. THUNDERBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0520FCS

Device Problems Degraded (1153); Failure to Align (2522)

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

Event Date 02/05/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that during a rectal resection they observed an error message indicating that the tip was defective.There were no reports of patient harm associated with this event.

Manufacturer Narrative

The device was returned to olympus, during testing and inspection the customer¿s complaint was confirmed.Additionally, the probe is cracked at 12,5 mm from the distal end site, the tissue pad in the grasping section was worn away, and a part of the tissue pad was peeled away.The metal part of the grasping section is visible and the tissue pad in the grasping section was torn with no missing part.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.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The b5 was corrected to include the reportable malfunction found during the device evaluation.The h6 coding was corrected to reflect the reportable malfunction.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that a short circuit error occurred by the following situation: ·during output in seal & cut mode, the probe came in contact with hard tissue, metal or a surgical instrument.·the probe came in contact with the non-insulated area of grasping section because the tissue pad was worn away.The root cause is attributed to component failure.The event can be detected/prevented by following the instructions for use (ifu)which state: ¿ 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.

Event Description

The customer reported to olympus that during a rectal resection they observed an error message indicating that the tip was defective.The thunderbeat 5 mm, 20 cm, front-actuated grip type scissor was returned for evaluation.During the device evaluation, the following reportable malfunction was found: the tissue pad in the grasping section was worn away, and a part of the tissue pad was peeled away.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• Brand Name: THUNDERBEAT 5 MM, 20 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: 17032937
• MDR Text Key: 317226411
• Report Number: 9614641-2023-00767
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170383571
• UDI-Public: 04953170383571
• 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: 07/05/2023

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-0520FCS
• Device Lot Number: 29K 05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2022
• 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