MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONICBEAT 5 MM, 10 CM, INLINE GRIP; INSTRUMENT

Model Number	SB-0510IC
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There are two failed devices from the same lot associated with this event.These devices are captured in medwatches with patient identifiers (b)(6) and (b)(6).This medwatch is for the patient identifier (b)(6).Due diligence was performed for this event with additional information provided.The device is returned, and an evaluation completed for it.The user¿s complaint was confirmed.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.Upon inspection of the device, it was observed that tissue pad was worn, partly peeled.Root cause for the event cannot be conclusively determined.However, it is likely that the tissue pad was worn, partly peeled off, due to the ultrasound being output with the grasping part closed (including after the tissue was cut) without grasping the tissue.The instructions for use includes the following statements that warn against the issue: ·do not activate output 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 or vessel sealing is performed, apply light tension on the tissue so that users can confirm that they are transected.Also, stop activation immediately after tissue is transected.Otherwise, the grasping section, the tissue pad, or the probe tip may break and fall, 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.
Event or Problem Description
As reported for this event by the customer, within 30 minutes during a therapeutic thyroidectomy procedure the device tissue pad detached.Another device was used prior to this one.That device had the tissue pad detached as well.There were no error messages received for the issues.The detaching of the tissue pads was observed visually.The procedure was completed with a third device from the same lot with no delay.Patient did not need additional anesthesia.Total procedure time was less than two hours.There is no harm or adverse impact to the patient.The functional mode and settings at the time of the event was seal and cut 1, level 3.Device was inspected prior to use with no abnormality noted.The intelligent tissue monitoring (itm) setting was on during the procedure.The connections to the generator were checked.The cords of transducer and other medical device cords were not bundled together.

• Brand Name: SONICBEAT 5 MM, 10 CM, INLINE GRIP
• Common Device Name: INSTRUMENT
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16004324
• Report Number: 9614641-2022-00787
• Device Sequence Number: 6679257
• Product Code: LFL
• UDI-Device Identifier: 04953170308970
• UDI-Public: 04953170308970
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: SB-0510IC
• Device Lot Number: 25K 09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: USG-400ESG-400TD-SB400
• Patient Sex: Unknown