MAUDE Adverse Event Report: COVIDIEN SURGICAL TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	SIG45AXT
Medical Device Problem Codes	Break (1069); Misfire (2532); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: egiaustnd, egiaustnd endogia ultra univ std stap (lot#: p5j1184), egiaustnd, egiaustnd endogia ultra univ std stap (lot#: p5h0844), egiaustnd, egiaustnd endogia ultra univ std stap (lot#: p5j1006), sig45axt, tri 2.0 sig45axt 45 xtra thk 15 mm (lot#: n5f1811y), sig45axt, tri 2.0 sig45axt 45 xtra thk 15 mm (lot#: n5g1756y), sigtrsb60axt, sigtrsb60axt 60 mm xtr thk reinforced rel (lot#: n5f1708y), sigtrsb60axt, sigtrsb60axt 60 mm xtr thk reinforced rel (lot#: n4k1715y), sig60axt, tri 2.0 sig60axt 60 xtra thk 15 mm (lot#: n5e1419y), sig45ctavm, tri 2.0 sig45ctavm 45 ct vsclr med 12 mm (lot#: n5h1655y), sig60ctamt, tri 2.0 sig60ctamt 60 ct med thk 12 mm (lot#: n5e1962y), sig45axt, tri 2.0 sig45axt 45 xtra thk 15 mm (lot#: n5g1756y), sig30ctav, tri 2.0 sig30ctav 30 ct vsclr 12 mm (lot#: n5c1843y), sigtrs60amt, tri 2.0 sigtrs60amt 60 med thk 12 mm (lot#: 5241038nh), sig45axt, tri 2.0 sig45axt 45 xtra thk 15 mm (lot#: n5g1756y), sig45axt, tri 2.0 sig45axt 45 xtra thk 15 mm (lot#: n5e1419y), sigtrs60amt, tri 2.0 sigtrs60amt 60 med thk 12mm (lot#: 5241038nh).H3: evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.No information re garding the specific customer issue that occurred with the device was available.Upon examination of the sample, it was found that of device partially fired.The product analysis noted evidence that the device was not used as intended.This issue may occur if the user presses the open key prior to the i-beam reaching the end of the reload.Following retraction, the safety interlock feature will engage and prevent the reload from firing a second time.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.
Event or Problem Description
It was reported that during a procedure to treat a 6 cm tumor, three handles and one reload were difficult to fire, resulting in an extended surgical time.The surgeon used multiple cartridges because the device could not be fully activated.When the cartridge was closed on the lung, the anvil bounced back.It was noted that the handle was cracking.The device was replaced twice to resolve the issue.No patient complications were reported as a result of this event.Medtronic's initial evaluation of the incident device found that the reloads were partially fired with the interlock engaged.Staple pushers were visible at various points between the 2 and 3 cm cut lines.

• 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 55112-4391 ; 8006464633
• MDR Report Key: 24500856
• Report Number: 1219930-2026-01433
• Device Sequence Number: 21322134
• Product Code: GDW
• UDI-Device Identifier: 10884521543607
• UDI-Public: (01)10884521543607(17)300630(10)N5G1756Y(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/03/2026

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: N5G1756Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown