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

Model Number	AESR60P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
An aeon endostapler 4.0mm/60mm purple reload was used in a sleeve gastrectomy procedure by dr.(b)(6) on (b)(6) 2022.Two aeon reloads had already been fired (aesr60p) when the doctor was about to fire the third reload.A strange sound was initially heard during firing.After complete firing and retraction of the reload, it was observed that no staples were released.The surgery was delayed more than 30 minutes.
Additional Manufacturer Narrative
The root cause of the reported behavior could not be determined.The investigation results indicate that the reload was not fired, since the wedge was still in the home position.The architecture of the reload makes it impossible for the reload to have been fired and the wedge to still be in the home position.As the reload was not fired, there is nothing to indicate that the reload investigated would have resulted in the reported harm.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: AEON ENDOSCOPIC STAPLER
• Common Device Name: 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: 15707668
• Report Number: 3012998149-2022-00005
• Device Sequence Number: 6630630
• Product Code: GDW
• UDI-Device Identifier: 00851574008721
• UDI-Public: (01)00851574008721(17)270630(10)22BR505
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K182380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: AESR60P
• Device Lot Number: 22BR505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown