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 Problem Melted (1385)

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

Event Type  malfunction  

Manufacturer Narrative

The device has been returned but the device evaluation is not yet begun.As such, a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as any relevant new information becomes available.

Event Description

As reported for this event by the customer, midway through a therapeutic open upper abdominal operation (multivisceral tumor resection) procedure, the device tissue pad suddenly melted.The procedure was completed with a new similar device with a slight delay.There is no harm or adverse impact to the patient.The intelligent tissue monitoring (itm) setting is usually on during the procedure.The user is very experienced with the device and was somewhat confused at the occurrence of the event.

Manufacturer Narrative

Additional information has been received for this event.The returned device has been evaluated.The device return date and the device manufacture date is available.This supplemental report is being submitted to provide this information.Event date is not known and the serial numbers of the device used in conjuction with the device for the event are not known.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The returned device evaluation is completed.The user¿s complaint was confirmed.Upon inspection of the device, it was observed that the device the tissue pad in the grasping section was worn away, and a part of the tissue pad was peeled away.There were no missing parts to the tissue pad.The coating of the probe and coating of the grasping part was also peeled.Based on previous investigation results, it can be inferred that a likely cause of the peeling of the tissue pad might be the following.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 and 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 coating of the grasping section could have come off when dirt such as burn was scraped off with something hard.It has been confirmed that the probe coating peels off if the device is handled as below.However, it could not be conclusively determined if such handling actually caused the reported phenomenon.Activate the device in seal and cut mode for a long duration while no tissue is grasped by the grasping section and the distal end of the probe.Activation in seal and cut mode continued after completion of a tissue cutting is also included in such activation.The instructions for use includes the following statements that warn against the issue: ·do not activate output in seal and 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 and 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 tissue stuck 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.

Event Description

Addendum dec 14, 2022: the settings at the time of the event were 1/3.An unknown alarm was received for the device at the time of the event.The device was not checked prior to use.The device system used is checked once a year for a safety check.

• 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: 15904009
• MDR Text Key: 308012214
• Report Number: 9614641-2022-00697
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• 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: 25K06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2022
• 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
• Treatment: USG400ESG400