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

Model Number AESR60T

Device Problems Retraction Problem (1536); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 03/27/2019

Event Type  Injury  

Manufacturer Narrative

The reload was received loaded onto the handle.No damage was observed on the handle.It was received as expected and components were in their usual state.Upon reload inspection, two components were found to be affected.High firing force due to over-indicated tissue thickness is a potential root cause of the damage, which would prevent unclamping the reload from the handle.No other reload components appeared to be affected.There were no patient complications, no additional incisions were required, it was not converted to an open procedure, and there was no potential for broken components to enter or remain in the patient cavity.The surgery was completed as a gastric bypass procedure and delayed more than 30 minutes.

Event Description

According to the reporter during a laparoscopic sleeve gastrectomy the reload remained clamped during the second firing, the reload jumped mid firing.Reload could not be advanced or retracted.Reload was removed by stapling.Stapling completed as gastric bypass procedure.

• Brand Name: AEON
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): LEXINGTON MEDICAL INC.; 11 executive park drive; billerica MA 01862 1318
• Manufacturer (Section G): LEXINGTON MEDICAL INC.; 11 executive park drive; billerica MA 01862 1318
• Manufacturer Contact: peter gerenz ; 11 executive park drive; billerica, MA 01862-1318 ; 6172099817
• MDR Report Key: 8586249
• MDR Text Key: 144268767
• Report Number: 3012998149-2019-00001
• Device Sequence Number: 1
• Product Code: GDW
• UDI-Device Identifier: 00851574008837
• UDI-Public: (01)00851574008837(17)210131(10)19AR130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: AESR60T
• Device Catalogue Number: AESR60T
• Device Lot Number: 19AR130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2019
• 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): Other
• Patient Age: 40 YR