MAUDE Adverse Event Report: LEXINGTON MEDICAL, INC. AEON ENDOSCOPIC STAPLER HANDLE; STAPLER, SURGICAL

Model Number	AETH160
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The aeon¿ endoscopic stapler consists of a handle and reload.During a laparoscopic appendectomy procedure, an aeth160 handle was used along with an unspecified reload.After the firing, the reload could not be retracted.The tissue was able to be removed from the reload.No additional surgery was necessary.No patient harm was reported.

• Brand Name: AEON ENDOSCOPIC STAPLER HANDLE
• 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
• MDR Report Key: 24953078
• Report Number: 3012998149-2026-00002
• Device Sequence Number: 18721039
• Product Code: GAG
• UDI-Device Identifier: 00851574008486
• UDI-Public: (01)00851574008486(17)280831(10)23BH585
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: AETH160
• Device Lot Number: 23BH585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/23/2023
• 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