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

Model Number HANDLE AESH160, RELOAD AESC45P

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

Results of the investigation indicated that the user failed to follow the instructions provided in the instructions for use (ifu).

Event Description

The aeon endostapler consists of a handle and reload.During a right upper lobectomy, an aeon reload was used on the bronchus.After the firing, the reload could not be retracted.To remove the reload from the tissue, the surgery was converted to an open approach.No further intervention, patient complications or harm associated with this incident.

• 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: kerry mcconnaughay ; 23 crosby drive; bedford, MA 01730
• MDR Report Key: 18993842
• MDR Text Key: 339245863
• Report Number: 3012998149-2024-00003
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00851574008998
• UDI-Public: (01)00851574008998(17)270331(10)22BR407
• Combination Product (y/n): N
• Reporter Country Code: EC
• PMA/PMN Number: K222210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HANDLE AESH160, RELOAD AESC45P
• Device Lot Number: 22BR407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• 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
• Patient Outcome(s): Required Intervention