MAUDE Adverse Event Report: Covidien Surgical Tri-Staple 2.0; STAPLE, IMPLANTABLE

Model Number	SIG45AXT
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the video-assisted thoracoscopic surgery, two reloads stapled but did not cut at all.The procedure time was extended by 10 minutes.The device was replaced, and a new reload was purchased to resolve the issue.
Additional Manufacturer Narrative
D10 concomitant products: egiaushort, egiaushort endogia ultra univ sht stap, (lot # p5m0576) sig60axt, tri 2.0 sig60axt 60 xtra thk 15mm, (lot # n5j1865y).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: Tri-Staple 2.0
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Covidien Surgical; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): Covidien Surgical; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50934872
• Report Number: 1219930-2026-06021
• Device Sequence Number: 9526029
• Product Code: GDW
• UDI-Device Identifier: 10884521543607
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIG45AXT
• Device Catalogue Number: SIG45AXT
• Device Lot Number: N2A0161Y
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Date Device Manufactured: 01/09/2022
• 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
• Patient Sex: Unknown