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

Model Number	AESR60T
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reload was received loaded onto the handle.No damage was observed on the handle.It was received as expected and components were in their usual state.Upon reload inspection, two components were found to be affected.High firing force due to over-indicated tissue thickness is a potential root cause of the damage, which would prevent unclamping the reload from the handle.No other reload components appeared to be affected.There were no patient complications, no additional incisions were required, it was not converted to an open procedure, and there was no potential for broken components to enter or remain in the patient cavity.The surgery was completed as a gastric bypass procedure and delayed more than 30 minutes.
Event or Problem Description
According to the reporter during a laparoscopic sleeve gastrectomy the reload remained clamped during the second firing, the reload jumped mid firing.Reload could not be advanced or retracted.Reload was removed by stapling.Stapling completed as gastric bypass procedure.

• Brand Name: AEON
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): LEXINGTON MEDICAL INC.; 11 executive park drive; billerica MA 01862 1318
• MDR Report Key: 8586249
• Report Number: 3012998149-2019-00001
• Device Sequence Number: 19229193
• Product Code: GDW
• UDI-Device Identifier: 00851574008837
• UDI-Public: (01)00851574008837(17)210131(10)19AR130
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K171589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2019

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: 01/31/2021
• Device Model Number: AESR60T
• Device Catalogue Number: AESR60T
• Device Lot Number: 19AR130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 05/07/2019
• 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
• Patient Age: 40 YR