MAUDE Adverse Event Report: Lexington Medical, Inc. AEON Endoscopic Powered Stapler; STAPLER, SURGICAL

Model Number	AESR60R
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction

• Brand Name: AEON Endoscopic Powered Stapler
• Common Device Name: STAPLER, SURGICAL
• 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: 50859580
• Report Number: 3012998149-2026-00006
• Device Sequence Number: 9508764
• Product Code: GAG
• UDI-Device Identifier: 00851574008660
• 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): 09/22/2026

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: Health Professional
• Device Model Number: AESR60R
• Device Lot Number: 26BR868
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2026
• 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
• Patient Sex: Unknown