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

Model Number	SIGCIR31MT
Medical Device Problem Codes	Failure to Cut (2587); Device Displays Incorrect Message (2591); Difficult to Open or Close (2921)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: sigcirxl signia circ adapt x lng length (serial# (b)(6) sigphandle-rfb, sig power handle sigphandle-rfb (serial# (b)(6) sigpshell, sig power sigpshell control shell (lot# unknown).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 robotic laparoscopic sigmoid colon procedure, the device was appearing to fire but did not cut, a yellow indicator for both the adapter and reload was shown.The device attempted to open or advance the tilt top anvil but did not, and the screen remained yellow on the reload lane during the sigmoid circular stapling step.The surgical time was extended by approximately 45 minutes.A new anastomosis was created and a manual circular stapler was used to resolve the issue.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted of the anvil noted that the anvil was tilted and matched the reload.There was no noted damage to the grasping notch and anvil splines.The anvil cut ring was partially severed.Visual inspection of the reload noted that the instrument was fully fired.The pushers were visible above the cartridge.The knife blade showed signs of normal use.A design/software assessment was performed for this event.The design assessment concluded related to complaint full details of this assessment are available in the corresponding task.It was reported that during a robotic laparoscopic sigmoid colon procedure, the device was appearing to fire but did not cut, a yellow indicator for both the adapter and reload was shown.The device attempted to open or advance the tilt top anvil but did not, and the screen remained yellow on the reload lane during the sigmoid circular stapling step.The reported issue was confirmed.The most likely cause could not be established from the information available.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.

• 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: 24520948
• Report Number: 1219930-2026-01471
• Device Sequence Number: 13201331
• Product Code: GDW
• UDI-Device Identifier: 10884521703742
• UDI-Public: (01)10884521703742(17)280930(10)N5K1294UY
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K182475
• 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,Followup
• Report Date (Section B): 04/17/2026

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: SIGCIR31MT
• Device Catalogue Number: SIGCIR31MT
• Device Lot Number: N5K1294UY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Age: 61 YR
• Patient Sex: Female