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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are two failed devices associated with this event.These devices are captured in medwatches with patient identifiers (b)(6) (lot number kr142453) and (b)(6) (lot number kr233457).This medwatch is for the patient identifier (b)(6).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 or Problem Description
As reported for this event by the customer two devices failed with broken probes in a rectal excision procedure.One and a half hour into the procedure, the device probe broke of the first device broke.A second device was used to continue the procedure.The second device probe broke after one hour of use.There is no reported harm to the patient.
Additional Manufacturer Narrative
Additional information has been received for this event.The device has been evaluated.This supplemental report is being submitted to provide this information.The device evaluation has been completed.The user¿s complaint of broken probe was not confirmed.Upon inspection and testing, it was observed that the tissue pad in the grasping section was worn away, and a part of the tissue pad was peeled away.The tissue pad in the grasping section was torn with no missing part.There was no crack and breakage in the probe.The probe was scratched with peeling coating and presence of contact mark.When the probe check was performed, no abnormality occurred, and the device could output.The grasping section jaw had coating peeling and scratched.
Event or Problem Description
Addendum dec 5, 2022: the device probe broke off in the patient.The broken piece was successfully retrieved from the patient body laparoscopically.The procedure was completed with approximately five minutes delay with no clinical relevance with a new similar device.Addendum dec 15, 2022: upon evaluation of the device, it was observed that the tissue pad in the grasping section was worn and peeled back.There was no missing part to the tissue pad.This is a reportable malfunction of the device.
Additional Manufacturer Narrative
Additional information has been received for this event and for the evaluation.This supplemental report is being submitted to provide this information.Please see the updates in sections: b3, b5, g2, g3, g6, h2, h6, and h10.Information on devices used in conjunction with the device for this event is 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 at inpsection.Since the probe broken was confirmed with a similar complaint, (b)(4), we assume that this complaint is the second product.The exact cause of the event could not be exclusively identified.However based on the device evaluation and the past investigation results, it is likely the peeling of the tissue pad occurred by the following reason: grasping section was closed without grasping anything while the output in seal and cut mode was activated, (this includes after tissue resection) causing the tissue pad to wear and peel off.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 was handled as follows.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 or Problem Description
Addendum (b)(6) 2022: the procedure was therapeutic.An unknown error message was received at the time of the event.The device was inspected with a probe check prior to use with no anomaly found.The generator was not inspected.

• Brand Name: THUNDERBEAT 5 MM, 45 CM, FRONT-ACTUATED GRIP TYPE S
• Common Device Name: 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: 15903565
• Report Number: 9614641-2022-00694
• Device Sequence Number: 20277538
• Product Code: GEI
• UDI-Device Identifier: 04953170383519
• UDI-Public: 04953170383519
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2023

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
• Operator of Device: Health Professional
• Device Model Number: TB-0545FCS
• Device Lot Number: KR142453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 12/05/2022; 12/21/2022
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 12/16/2022; 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown