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

Model Number	AESC45P
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
During surgery, when stapling the bronchus with an aeon stapler with a 45 purple reload, the stapler would not release off the tissue.
Additional Manufacturer Narrative
The device was not returned for investigation, after a number of attempts.Root cause: unknown.Did device malfunction? unknown.Did device fail to meet specification? unknown.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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: 15524768
• Report Number: 3012998149-2022-00002
• Device Sequence Number: 2520369
• Product Code: GDW
• UDI-Device Identifier: 00851574008998
• UDI-Public: (01)00851574008998(17)250831(10)20AR407
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/30/2022

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 Expiration Date: 08/31/2025
• Device Model Number: AESC45P
• Device Lot Number: 20AR407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2020
• 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: STAPLER HANDLE MODEL AESH160 LOT 22BH553
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown