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

Model Number	SIG45AXT
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, preoperatively, during set up, the reload was connected to the manual stapler, an attempt to check the opening and closing was done but there was no response, so a new cartridge was taken out, and attempted to check the opening and closing, but a snapping sound was heard, and it could not be opened or closed.The device was changed to a power stapler, and when the new cartridge was used, the firing was performed without any problems.It was not used on the patient.There was no patient involved.
Additional Manufacturer Narrative
D10 concomitant products: sig45axt, tri 2.0 sig45axt 45 xtra thk 15mm (lot # n5e1595y); egiaustnd, egiaustnd endogia ultra univ std stap (lot # p5e0904).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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 correction: a1 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the jaw of the reload was open.Functional testing noted that the reload was loaded into a representative handle.The interlock was overridden and the reload was applied to test media.All staples were placed, and test media was transected.The reload interlock was tested and found to function properly.It was reported that the jaws would not close.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the device was pre-fired.The reload was pre-fired and the interlock was engaged.Staples were protruding from the proximal end of the staple cartridge channel.The sled was slightly advanced.The product analysis noted evidence that the device was not used as intended.This issue can occur if the firing button had been partially compressed and then the open button was pressed after pressing the green firing button.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: failure to completely fire the reload will result in an incomplete cut or incomplete staple formation, which may result in poor hemostasis or leakage.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 55112-4391 ; 8006464633
• MDR Report Key: 24408328
• Report Number: 1219930-2026-01197
• Device Sequence Number: 9748479
• Product Code: GDW
• UDI-Device Identifier: 10884521543607
• UDI-Public: (01)10884521543607(17)300430(10)N5E1595Y(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

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: N5E1595Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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