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

Model Number HANDLE AETH060 AND RELOAD AESR60P

Device Problem Retraction Problem (1536)

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

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

N/a.

Event Description

The aeon endostapler system consists of a handle and reload.During a thoracic wedge resection procedure., the surgeon was not able to open the reload after firing.The reload had to be removed with some surrounding tissue.Since an additional incision was required to remove the tissue and the surgery was delayed, this incident is being reported in abundance of caution.No patient harm.Surgeon had described the tissue as fibrotic.

• 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 ; 6172099817
• MDR Report Key: 18827121
• MDR Text Key: 337214957
• Report Number: 3012998149-2024-00001
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00851574008653
• UDI-Public: (01)00851574008653(17)280930(10)23BH621
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K222210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HANDLE AETH060 AND RELOAD AESR60P
• Device Lot Number: HANDLE 23BH621 AND RELOAD UNKN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2023
• 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
• Patient Outcome(s): Required Intervention