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

Catalog Number AESH160

Device Problem Retraction Problem (1536)

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

Event Date 08/21/2023

Event Type  malfunction  

Event Description

An aeon endostapler handle medium was used with a 45 purple reload during a lobectomy procedure on (b)(6) 2023.During the procedure the aesr45p was fired on the bronchus, after the firing the reload would not unclamp and retract from the tissue.The surgeon needed to use a scalpel to release the reload and suture the bronchus.No patient harm.During a follow-up conversation, the surgeon stated that the tissue had been previously irradiated and was significantly inflamed.They also said the tissue was thick and in hindsight, a 45mm black reload may have been more appropriate for the tissue.

Manufacturer Narrative

The device was returned and investigated no defects were found in the returned product.

• 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: 17741105
• MDR Text Key: 323921405
• Report Number: 3012998149-2023-00005
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00851574008004
• UDI-Public: (01)00851574008004(17)280229(10)23BH128
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AESH160
• Device Lot Number: 23BH128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• 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: AESR45P AEON¿ ENDOSCOPIC STAPLER 4.0MM/45MM RELOAD
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Female