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	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation, and the customer's allegation was confirmed.Additionally, the device evaluation found the energy was activated while the grasping jaw was closed while not being contact with tissue.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.When shipped, the device was in accordance with all specifications.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, it is likely the activation of the output on the device without grasping tissues caused the pad to separate and peel.This issue is addressed in the instructions for use (ifu) where users are warned against activating the output of the device without patient tissue being present as the activation will cause damage to the device, making it unusable.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus the sonicbeat 5 mm, front actuated grip tissue pad rolled up and began to separate.The issue was found during a therapeutic, thoracoscopic partial resection of the right middle lobe of the lung towards the beginning of the procedure.The device was replaced with a similar device which was used to complete the procedure, and there were no reports of patient harm or impact.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17218235
• Report Number: 9614641-2023-00920
• Device Sequence Number: 2985337
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/28/2023

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: 09K08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2020
• 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: TD-SB400 - SERIAL UNKNOWN; USG-400 - SERIAL UNKNOWN
• Patient Sex: Unknown