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

Model Number	AESR45P
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An aeon+ handle short was used with an aesr45p reload in a wedge resection performed on (b)(6) 2023.During the last firing the surgeon heard a "pop" when attempting to retract the handle and it would not move.The lexington representative on site instructed the surgeon to jiggle the trigger and retraction knob.After several attempts, the surgeon was still unable to retract.He ended up dissecting around the left side of the reload to free it.Tissue was cut from the jaws of the reload without causing further harm to the patient or additional bleeding.
Additional Manufacturer Narrative
After investigation, the level one root cause for being unable to retract was determined to be the leaf stack buckling out the side of the reload.This buckling of the leaf stack was likely a result of excessive force at the end of the reload.This excessive force is also indicated by the two broken rack teeth.The position of the broken teeth and the position of the buckled leaf stack is at the end of the reload, which indicates this force was likely not a result of tissue thickness, but a result of force exerted by the surgeon at the end of firing.The surgeon should stop squeezing the trigger when the end of the reload is reached as stated in the instructions for use 900299 section 2.3.6.Therefore, the level two root cause was user error.

• Brand Name: AEON PLUS ENDOSCOPIC STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): LEXINGTON MEDICAL; 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: 17424414
• Report Number: 3012998149-2023-00001
• Device Sequence Number: 18056759
• Product Code: GDW
• UDI-Device Identifier: 00851574008868
• UDI-Public: (01)00851574008868(17)270930(10)22BR657
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K182380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/31/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: AESR45P
• Device Lot Number: 22BR657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AEON ENDOSCOPIC STAPLER HANDLE AESH060 LOT 23BH500
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown