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

Model Number	AESR45P
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: after investigation, it was determined that the level one root cause for the inability to fully retract and unclamp the reload was that the blade assembly was broken.The level two root cause may have been attributed to the device continuing to be fired once the blade assembly had reached the end of the reload.This was evidenced by the location of the i-beam upon return of the reload.The handle was received as expected and no defects were found during the visual inspection, functional testing, and disassembly.Did device malfunction? yes.Did device fail to meet specification? no.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 endoscopic stapler 4.0mm/45mm purple reload was used with an aeon endoscopic stapler handle - medium in a low anterior resection procedure by the physician on (b)(6) 2021.The physician fired the reload on the rectum and heard a crack sound during retraction.The orange retraction knob was pulled back completely, but the reload remained clamped on the tissue.The reload was removed by stapling/cutting.Surgery was delayed by more than 30 minutes.No patient harm.

• Brand Name: AEON ENDOSCOPIC STAPLER
• Common Device Name: IMPLANTABLE STAPLE
• Manufacturer (Section D): LEXINGTON MEDICAL, INC.; 11 executive park drive; billerica MA 01862
• MDR Report Key: 11608425
• Report Number: 3012998149-2021-00001
• Device Sequence Number: 17018940
• Product Code: GDW
• UDI-Device Identifier: 00851574008868
• UDI-Public: (01)00851574008868(17)241231(10)19AR303
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K182380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: AESR45P
• Device Lot Number: 19AR303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other