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

Model Number	SIGCIR31XT
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Cut (2587); Device Displays Incorrect Message (2591); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: sigcirxl, sigcirxl signia circ adapt x lng length (serial # (b)(6) sigphandle-rfb, sig power handle sigphandle-rfb (serial # (b)(6).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 colectomy to create an anastomosis in the distal colon, when closing the anvil, the excessive force icon appeared.It was noted that the icon was intentional, to wait several seconds for anvil to continue to close and reach 100% closed.Once the firing button illuminated, the physician proceeded to fire as usual.The staple icon illuminated as usual, and the knife cutting graphic illuminated as usual, but then showed a spike error graphic for 1 second which was a red circle with line that appeared on the knife blade.The normal icon appeared instructing user to press up button to open anvil.As physician went to open anvil, the reload yellow swim lane error appeared.The anvil did open as usual, but the stapler was extremely difficult to remove from the anastomosis.The physician noted it felt as though the stapler did not cut all the way.After 2-3 minutes, the physician was able to wiggle the stapler out of the anastomosis and patient's body, but upon scoping, 1/4 of the anastomosis looked loose.It was noted that the procedure was extended by 10 minutes.The surgeon sutured over the anastomosis and proceeded with the case.

• Brand Name: TRI-STAPLE 2.0
• Common Device Name: STAPLER, SURGICAL
• 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: 24915757
• Report Number: 1219930-2026-02558
• Device Sequence Number: 13060550
• Product Code: GAG
• UDI-Device Identifier: 10884521703759
• UDI-Public: (01)10884521703759(17)281231(10)N6A1142UY(20)01
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K221629
• 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): 07/08/2026

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: SIGCIR31XT
• Device Catalogue Number: SIGCIR31XT
• Device Lot Number: N6A1142UY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2026
• 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: SEE H11
• Patient Age: 66 YR
• Patient Sex: Female