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

Model Number	AESR60B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After investigation, the root cause was unable to be determined.No issues were found with the reload that would indicate the product malfunctioned during use.All components were present, undamaged, and properly assembled.Additionally, all staples present on the device were properly formed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
An aeon endostapler 5.0mm/60mm black reload was used in a redo sleeve gastrectomy procedure by dr.(b)(6) on (b)(6) 2022.On the first fire, the handle would not work.The handle was replaced.On the last fire, all of the staples did not deploy, and there was considerable bleeding.The entire staple line was very bloody, and the surgeon had to suture the entire staple line.The surgery was delayed by more than 30 minutes.

• 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: 15663451
• Report Number: 3012998149-2022-00004
• Device Sequence Number: 12377305
• Product Code: GDW
• UDI-Device Identifier: 00851574008707
• UDI-Public: (01)00851574008707(17)270630(10)22BR524
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K182380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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: AESR60B
• Device Lot Number: 22BR524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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: Other
• Patient Sex: Unknown