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

Model Number	SIG45AXT
Medical Device Problem Codes	Misfire (2532); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, intra-operatively, the instrument made strange noise.The distal staple line was incomplete.The stapler cut but did not deploy the staples and some of the deployed staples did not form properly.The staple line bled.There was blood loss of 500cc or more.The staple line was resected and re-stapled to fix the issue.The issue resulted to the procedure changing to a lung lobectomy instead of segment resection.The surgical time was extended for 20 minutes.Medtronic¿s initial evaluation of the incident device found that staple pushers were visible at the 2cm cut line.
Additional Manufacturer Narrative
D10 concomitant products: sig45axt, tri 2.0 sig45axt 45 xtra thk 15mm, (lot # n5g1756y); egia45amt, egia45amt egia 45 artic med thick sulu, (lot # n5d1372y); egiaustnd, egiaustnd endogia ultra univ std stap, (lot # p5g1228) 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: g3, h3, h6 h3 evaluation summary: "medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted that the first returned photo contained a view of the surgical site.A portion of staple line was noted as well as several fully formed staples.The second returned photo contained a zoomed out view of the same scene.The third returned photo contained a slightly different angle of the same scene.The reload was partially fired with the interlock engaged.The jaws were open.Staple pushers were visible at the 2cm cut line.The reload was loaded into a representative instrument (0802).The interlock was overridden and the reload was applied to test media.All remaining staples were placed, and test media was cleanly transected.The reload interlock was tested and found to function properly.It was reported that the device partially fired.The reported issue was not used as intended the product analysis noted evidence that the device was not used as intended.Replication of the partial fire condition with interlock engagement may occur when the firing handle has not been completely cycled.If the instrument return knobs are retracted at any point once the firing cycle has begun, the reload will engage into safety interlock and prevent further attempts to fire by ceasing the placement of staples and tissue transection and prevent patient harm.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: failure to completely fire the reload will result in an incomplete cut and/or incomplete staple formation, which may result in poor hemostasis and/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: 24024233
• Report Number: 1219930-2026-00167
• Device Sequence Number: 10583446
• 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: GM
• PMA/510(K) Number: K160176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 01/27/2026

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: 12/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 01/27/2026
• 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 Age: 85 YR
• Patient Sex: Female
• Patient Weight: 60 KG