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

Model Number	RELOAD AESR45W, HANDLE AETH260
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned product did not yield a definitive root cause.Damage to the components that interlock to enable device retraction was noted.However, it was unable to be determined whether this damage was caused during the process of re-establishing the connection between the components.
Event or Problem Description
The aeon endostapler consists of a handle and reload.During a duodenal switch procedure, an aeon reload was used on the duodenum.After the firing, the reload could not be retracted.With the assistance of lexington medical employees, the surgeon was able to reestablish a connection between the handle and reload to retract the reload and remove it from the tissue.No further action, patient complications, or harm is associated with this incident.

• 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: 22028155
• Report Number: 3012998149-2025-00002
• Device Sequence Number: 20951289
• Product Code: GAG
• UDI-Device Identifier: 00851574008899
• UDI-Public: (01)00851574008899(17)300228(10)25BR344
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• 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
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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: RELOAD AESR45W, HANDLE AETH260
• Device Lot Number: RELOAD 25BR344, HANDLE 25BH256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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