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

Model Number	HANDLE AETH060 AND RELOAD AESR60P
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
N/a.
Event or Problem Description
The aeon endostapler system consists of a handle and reload.During a thoracic wedge resection procedure., the surgeon was not able to open the reload after firing.The reload had to be removed with some surrounding tissue.Since an additional incision was required to remove the tissue and the surgery was delayed, this incident is being reported in abundance of caution.No patient harm.Surgeon had described the tissue as fibrotic.

• 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 ; 6172099817
• MDR Report Key: 18827121
• Report Number: 3012998149-2024-00001
• Device Sequence Number: 7935397
• Product Code: GDW
• UDI-Device Identifier: 00851574008653
• UDI-Public: (01)00851574008653(17)280930(10)23BH621
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2024

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 AETH060 AND RELOAD AESR60P
• Device Lot Number: HANDLE 23BH621 AND RELOAD UNKN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2023
• 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