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

Catalog Number	AESC45W
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After investigation, it was determined that the root cause of being unable to retract was a buckled leaf stack.
Event or Problem Description
An aeon endostapler handle short (aesh060) was used with a white aesc45w reload in a liver resection procedure performed by the dr.On (b)(6) 2023.During the procedure when firing the aesc45w reload the reload fired but did not open.The surgeon was able to get the reload off the tissue and no patient harm.

• 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: 18080346
• Report Number: 3012998149-2023-00007
• Device Sequence Number: 6789177
• Product Code: GDW
• UDI-Device Identifier: 00851574008110
• UDI-Public: (01)00851574008110(17)271130(10)22BR732
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 222210
• 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): 11/06/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AESC45W
• Device Lot Number: 22BR732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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: AESH060 AEON ENSDSCOPIC HANDLE SHORT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown