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

Model Number	AESR60P
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two reloads were reported to have the same issue.Manufacturing date and expiration date of the aesr60p reload of lot 25br416 is reported in field h4.Additional reload (lot 25br443) was manufactured on 05/01/2025.
Event or Problem Description
The aeon endoscopic stapler consists of a handle and reload.During a thoracic lobectomy, the surgeon was using aesr60p reloads on normal lung parenchyma.It was reported that the pin between the catridge and the anvil had come loose and fallen into the site.The surgeon was able to retrieve the component out of the patient.No patient harm.

• 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: kerry mcconnaughay ; 23 crosby drive; bedford, MA 01730
• MDR Report Key: 22581695
• Report Number: 3012998149-2025-00004
• Device Sequence Number: 7985911
• Product Code: GAG
• UDI-Device Identifier: 00851574008721
• UDI-Public: (01)00851574008721(17)300430(10)25BR416
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 07/23/2025

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: AESR60P
• Device Lot Number: 25BR416, 25BR443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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