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

Model Number	SIG45AMT
Medical Device Problem Codes	Retraction Problem (1536); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a robotic laparoscopic lung wedge resection, when the reload was applied to transect the lung, the cartridge was completely fired but would not open and had difficulty retracting to the knife blade.The handle was removed during troubleshooting; however, the cartridge remained locked on the lung tissue, and the proximal end of the cartridge shaft broke off.Moreover, the handle cracked.To resolve the issue, the cartridge was resected from the lung for removal, and the tissue was re-stapled.The surgical case was extended by approximately one hour.Medtronic's initial evaluation of the incident device found incomplete retraction condition.
Additional Manufacturer Narrative
D10 concomitant product: egiaustnd, egiaustnd endogia ultra univ std stap (lot#p6d1123); sig45ctamt, tri 2.0 sig45ctamt 45 ct med thk 12mm (lot#n6d1160y); sig45amt, tri-staple 2.0 45 artic med thick sulu (lot#p6e0843) 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; sabanetas industrial park; ponce PR 00716 -440
• Manufacturer (Section G): Covidien; sabanetas industrial park; ponce PR 00716 -440
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50871409
• Report Number: 2647580-2026-02803
• Device Sequence Number: 18498171
• Product Code: GDW
• UDI-Device Identifier: 10884521808959
• UDI-Public: (01)10884521808959(17)310228(10)P6C0744(20)01
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: SIG45AMT
• Device Catalogue Number: SIG45AMT
• Device Lot Number: P6C0744
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2026
• 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: PLEASE SEE NOTE ON H11
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 225 LB
• Patient Race: White