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

Model Number	AESR60R
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	09/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After investigation, it was determined that the level one root cause for no staples present was that the reload had been re-fired.The level two root cause was determined to be a combination of user error and product malfunction.Reloads are single-use devices that are not intended to be re-fired, as per the warning in the instructions for use 900299 section 1.4.9.However, a single-use lockout is present on all reloads to prevent re-firing of used reloads.After investigation of components that could result in inability to retract at the beginning of the firing, the root cause for inability to abort the firing could not be determined.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 endostapler 3.25mm/60mm orange reload was used in a gastric bypass procedure by dr.(b)(6) on (b)(6) 2022.An orange reload was successfully fired transverse across the stomach.The stapler was reloaded with an orange reload.After the stapler clamped down, the user had to apply excess force to fire.A pop was heard.The user tried to abort the reload but was unable to.After completion of firing and retraction there were no staples formed, and a hole was left in the patient's stomach.It was sutured to repair.Additional reloads were used on the same handle to complete the case.The surgery was delayed more than 30 minutes.

• 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: 15670578
• Report Number: 3012998149-2022-00003
• Device Sequence Number: 6496721
• Product Code: GDW
• UDI-Device Identifier: 00851574008660
• UDI-Public: (01)00851574008660(17)270228(10)22BR376
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K182380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/24/2022

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 Model Number: AESR60R
• Device Lot Number: 22BR376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2022
• 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
• Patient Sex: Unknown