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

Model Number	AESR45P
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Bronchial Hemorrhage (4456)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No definitive root cause could be found by inspecting the returned reload.No defects were noted, nor were extreme wear or damage present.Based on provided information and inspection of the returned product, it is possible that the following properties of the procedure could have contributed to malformed staples, in descending order of suspected contribution: that the tissue was perceived as thick by the sales representative, and that the surgeon fired quickly and did not allow the lung tissue to compress.The fibrotic nature of the tissue.A staple from the prior firing was dragged along the cut line of this firing.
Event or Problem Description
An aeon aesh060 handle was used with an aesr45p reload on the third firing of a vats wedge resection on thick parenchyma tissue.The reload was fired fully and retracted.Upon opening of the jaws, the surgeon noted there was bleeding and unformed staples along the staple line.

• 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: 17327065
• Report Number: 3012998149-2023-00003
• Device Sequence Number: 6658155
• Product Code: GDW
• UDI-Device Identifier: 00851574008875
• UDI-Public: (01)00851574008875(17)271031(10)22BR671
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K222210
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AESR45P
• Device Lot Number: 22BR671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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: AEON ENDOSCOPIC SHORT HANDLE AESH060 LOT 23BH527
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown