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

Model Number	HANDLE AETH160, RELOAD AESR60P
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The aeon¿ endoscopic stapler consists of a handle and reload.During a esophagectomy procedure, an aeth160 handle was used along with an aesr60p reload.After the firing, the reload could not be retracted.The tissue was able to be removed from the reload, resulting in a minor injury.No additional surgery was necessary.The patient received endovac therapy, no further patient harm was reported.

• Brand Name: AEON ENDOSCOPIC 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: 23556380
• Report Number: 3012998149-2025-00007
• Device Sequence Number: 18668977
• Product Code: GAG
• UDI-Device Identifier: 00851574008486
• UDI-Public: (01)00851574008486(17)300331(10)25BH608
• 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: 2025
• 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): 11/13/2025

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: HANDLE AETH160, RELOAD AESR60P
• Device Lot Number: HANDLE 25BH608, RELOAD 25BR581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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
• Patient Sex: Unknown