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

Catalog Number	AESR45R
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An aesh160 handle and aesr45r reload were used during a procedure on an esophagus on a (b)(6) 2023.The tip of the reload inadvertently contacted the aorta resulting in a tear.The surgeon had to convert to open surgery.
Additional Manufacturer Narrative
The reload could not be examined as it was not returned.Based on the communication with the sales representative who was present during the procedure, the fit through the trocar was not tight and the anvil was not described as sharp.It is suspected that the reload was inserted with force and contacted the aorta resulting in the tear.Thus, the tear was likely a result of user error.

• 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: rainer maas ; 23 crosby drive; bedford, MA 01730 ; 6172099817
• MDR Report Key: 17741114
• Report Number: 3012998149-2023-00006
• Device Sequence Number: 20470836
• Product Code: GDW
• UDI-Device Identifier: 00851574008813
• UDI-Public: (01)00851574008813(17)280531(10)23BR202
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: 222210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2023

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 Catalogue Number: AESR45R
• Device Lot Number: 23BR202
• 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: 08/25/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ESH160 AEON¿ ENDOSCOPIC STAPLER HANDLE MEDIUM LOT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown