MAUDE Adverse Event Report: LEXINGTON MEDICAL INC. AEON ENDOSCOPIC STAPLER

Model Number	AESC45G
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Bronchial Hemorrhage (4456)
Date of Event	07/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After investigation, the level one root cause for bleeding was that the surgeon had fired the reload with a hem-o-lock in the reload jaws, resulting in multiple malformed staples.Firing a reload over an obstruction is known to result in staple malformation and therefore poor hemostatic performance.The ifu used for this region is most likely the spanish language version of 900298.In the spanish version of 900298 rev-t (the most recent revision that was approved by colombian authorities at time of the event), warning #5 on page 7 indicates that firing over an obstruction can result in incorrectly formed staples.The level two root cause is therefore user error.
Event or Problem Description
Five 45 grey curved reloads and one 30 white curved reload were used for a lobectomy procedure that was performed on (b)(6) 2023.During the procedure the surgeon fired the reload to seal an artery, the staple line did not fully seal the artery and the patient bled.

• Brand Name: AEON ENDOSCOPIC STAPLER
• Common Device Name: AEON ENDOSCOPIC STAPLER
• 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: 17626071
• Report Number: 3012998149-2023-00004
• Device Sequence Number: 7318696
• Product Code: GDW
• UDI-Device Identifier: 00851574008943
• UDI-Public: (01)00851574008943(17)270731(10)22BR541
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 08/25/2023

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 Model Number: AESC45G
• Device Lot Number: 22BR541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AESC45G AEON ENDOSCOPIC STAPLER 2.0MM/45MM CURVED; AESC45G AEON ENDOSCOPIC STAPLER 2.0MM/45MM CURVED; AESC45G AEON ENDOSCOPIC STAPLER 2.0MM/45MM CURVED; AESC45G AEON ENDOSCOPIC STAPLER 2.0MM/45MM CURVED; ASR30WC AEON ENDOSCOPIC STAPLER 2.5MM/30MM CURVED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown