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

Model Number	HANDLE AESH160, RELOAD AESC45P
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	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The aeon endostapler consists of a handle and reload.During a right upper lobectomy, an aeon reload was used on the bronchus.After the firing, the reload could not be retracted.To remove the reload from the tissue, the surgery was converted to an open approach.No further intervention, patient complications or harm associated with this incident.
Additional Manufacturer Narrative
Results of the investigation indicated that the user failed to follow the instructions provided in the instructions for use (ifu).Note: this report is being submitted as a follow-up to report 3012998149-2024-00003.Initial report 3012998149-2024-00003 was submitted within the 30-day timeframe of the event on (b)(6) 2024.The purpose of this report submission is to clarify the date of the initial report ((b)(6) 2024) and add the date of the event (03/06/2024).

• Brand Name: AEON ENDOSCOPIC STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 19059876
• Report Number: 3012998149-2024-00004
• Device Sequence Number: 5859337
• Product Code: GDW
• UDI-Device Identifier: 00851574008998
• UDI-Public: (01)00851574008998(17)270331(10)22BR407
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K222210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HANDLE AESH160, RELOAD AESC45P
• Device Lot Number: 22BR407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown