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

Model Number	AESR60W
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	02/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The aeon endostapler system consists of a handle and reload.During a laparoscopic revision of a gastroenterostomy, aeon reloads were used on duodenum.Procedure was completed with no issues and no staple line concerns were noted at the end of the procedure.However, the patient had to be taken back into the or due to two separate postoperative bleeds from the small bowel.It was confirmed that the staple line did not come apart and that the staple formation looked appropriate.It was not identified where the bleeding was observed.The surgeon applied additional suture and resolved the bleeding.No further intervention, patient complications or harm associated with this incident.No device problem was identified, this event is being reported in abundance of caution.
Additional Manufacturer Narrative
The product could not be evaluated, as it was discarded after use.However, the device history record was reviewed and no issues were identified.

• 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: 18993348
• Report Number: 3012998149-2024-00002
• Device Sequence Number: 12663811
• Product Code: GDW
• UDI-Device Identifier: 00851574008905
• UDI-Public: (01)00851574008905(17)280930(10)23BR544
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 03/27/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: AESR60W
• Device Lot Number: 23BR544
• Was Device Available for Evaluation?: No
• 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: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown