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

Model Number	AESR60B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a manufacturing record evaluation was performed for the finished device.This investigation revealed that the lot aligned with a manufacturing process flow change.Due to this alignment, lexington medical contacted all accounts that may have received reloads manufactured with this manufacturing process and offered to exchange their affected inventory with inventory that has undergone additional inspection.As of this date, all known product in the u.S.Potentially affected has been exchanged.Also, no known related complaints have been received.A corrective and preventative action (capa) has been opened to further investigate, modify the manufacturing process, and add additional staple inspection checks.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
The physician reported that during the use of the aeon endoscopic stapler reload, staples were present in the implanted staple line, but multiple staples were missing.The precise number of missing staples was not reported.The device was not returned for investigation.A lexington medical representative was not present during the case.There was no patient impact reported.Surgery was not delayed by more than 30 minutes.The procedure was not converted to open surgery.

• 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: 10840597
• Report Number: 3012998149-2020-00001
• Device Sequence Number: 14226799
• Product Code: GDW
• UDI-Device Identifier: 00851574008714
• UDI-Public: (01)00851574008714(17)250731(10)20AR388
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/13/2020

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 Expiration Date: 07/31/2025
• Device Model Number: AESR60B
• Device Lot Number: 20AR388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2020
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1