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

Model Number	AETH060
Medical Device Problem Codes	Retraction Problem (1536); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned handle was tested and evaluated, and no abnormalities were identified.The handle device history record was reviewed and no issues were observed.The associated reload was not returned and could therefore not be evaluated.As the reload was not returned, device analysis results could not determine what caused the product problem.
Event or Problem Description
The aeon¿ endoscopic stapler consists of a handle and reload.During a distal pancreatectomy procedure, an aeth060 handle was used along with an unspecified reload.After the firing, staples were malformed and the surgeon was unable to retract the device.The tissue was able to be clipped and 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 01730
• MDR Report Key: 25670753
• Report Number: 3012998149-2026-00004
• Device Sequence Number: 14894168
• Product Code: GAG
• UDI-Device Identifier: 00851574008653
• UDI-Public: (01)00851574008653(17)310430(10)26BH140
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/30/2026

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
• Device Model Number: AETH060
• Device Lot Number: 26BH140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2026
• 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