MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SONICBEAT 5 mm, 45 cm, Front-actuated Grip; INSTRUMENT

Model Number	SB-0545FC
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer returned the instrument for a separate issue.During the initial evaluation of the returned device, it was observed that the tissue pad was peeled off.There was no patient involvement.
Additional Manufacturer Narrative
Based on the final investigation of the device, the initial evaluation findings were confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: 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 & 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 peeled away.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: SONICBEAT 5 mm, 45 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 ; +1(508)207-7661
• MDR Report Key: 50774323
• Report Number: 9614641-2026-00913
• Device Sequence Number: 21467207
• Product Code: LFL
• UDI-Device Identifier: 04953170370571
• UDI-Public: 04953170370571
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: Other
• Device Model Number: SB-0545FC
• Device Lot Number: 45K
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown