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

Model Number	AESR60R
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Gastrointestinal Hemorrhage (4476)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An aeon endostapler 3.25mm/60mm orange reload was used with an aeon endostapler handle - long in a sleeve gastrectomy procedure.The procedure took place on (b)(6) 2022 and lexington medical was made aware of the event on november 2, 2022.The stapler cut but did not staple.No patient harm.
Additional Manufacturer Narrative
After investigation, it was determined that the level one root cause for no staples present after retracting 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.

• 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: 15909148
• Report Number: 3012998149-2022-00006
• Device Sequence Number: 5391339
• Product Code: GDW
• UDI-Device Identifier: 00851574008677
• UDI-Public: (01)00851574008677(17)270630(10)22BR506
• 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
• 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): 12/02/2022

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: AESR60R
• Device Lot Number: 22BR506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (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 STAPLER HANDLE AESH260 LOT# 22BH66.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown