MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONICBEAT 5 MM, 20 CM, FRONT-ACTUATED GRIP; INSTRUMENT

Model Number	SB-0520FC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported to olympus during an operation, the sonicbeat tissue pad detached at the tip.The tissue pad did not fall off and no error was displayed.The doctor noticed the event and stopped using the subject device.The therapeutic video assisted neck surgery (vans) was completed by using a replacement device.There was no report of a procedural delay or patient harm associated with this event.
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.The tissue pad was worn and partially peeled off.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, additional information to d4, and a correction to g2.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, it's likely the tissue pad was worn and partly peeled off because the ultrasonic wave was activated with the grasping part closed (including after the tissue was cut) without grasping the tissue.The following is included in the instructions for use which state: "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".Olympus will continue to monitor field performance for this device.

• Brand Name: SONICBEAT 5 MM, 20 CM, FRONT-ACTUATED 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17445819
• Report Number: 9614641-2023-01066
• Device Sequence Number: 2710549
• Product Code: LFL
• UDI-Device Identifier: 04953170370601
• UDI-Public: 04953170370601
• 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,Followup
• Report Date (Section B): 09/26/2023

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: SB-0520FC
• Device Lot Number: 2XK05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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: ESG-400; TD-SB400; USG-400
• Patient Sex: Unknown