MAUDE Adverse Event Report: LEXINGTON MEDICAL, INC. AEON ENDOSCOPIC STAPLER; STAPLE, IMPLANTABLE

Model Number	AESC45P
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was observed that the returned reload displayed signs of being subjected to an abnormally high firing force by the user, highly likely due to the user firing on thick/dense tissue.Abnormally high firing forces due to challenging tissue nature may cause staple malformation.Based on provided information and inspection of the returned product, it is highly likely that the dense and cartilaginous properties of bronchial tissue could have contributed to malformed staples.
Event or Problem Description
The aeon¿ endoscopic stapler consists of a handle and reload.During a thoracic lobectomy, an aeon¿ endoscopic stapler handle was used with a aesc45p reload.After firing on the bronchus, the surgeon recognized that all staples were not closed in the correct "b" form.The surgeon needed to replace the incorrect staple line with suture.The issue resulted in 20 additional minutes to the procedure.No patient harm reported.

• Brand Name: AEON ENDOSCOPIC STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): LEXINGTON MEDICAL, INC.; 23 crosby drive; bedford MA 01730
• Manufacturer (Section G): LEXINGTON MEDICAL, INC.; 23 crosby drive; bedford MA 01730
• Manufacturer Contact: sarah spinelli ; 23 crosby drive; bedford, MA 01730
• MDR Report Key: 24670099
• Report Number: 3012998149-2026-00001
• Device Sequence Number: 17422623
• Product Code: GDW
• UDI-Device Identifier: 00851574008998
• UDI-Public: (01)00851574008998(17)301130(10)25BR719
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K222210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: AESC45P
• Device Lot Number: 25BR719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Initial Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown