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

Catalog Number AESC45W

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

After investigation, it was determined that the root cause of being unable to retract was a buckled leaf stack.

Event 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
• Type of Device: 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
• MDR Text Key: 327551333
• Report Number: 3012998149-2023-00007
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00851574008110
• UDI-Public: (01)00851574008110(17)271130(10)22BR732
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 222210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AESH060 AEON ENSDSCOPIC HANDLE SHORT.
• Patient Outcome(s): Required Intervention