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)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Tissue Breakdown (2681); Insufficient Information (4580)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10.Concomitant products: sigphandle, sig power sigphandle handle (serial (b)(6)); sigcirstnd, sigcirstnd signia circ adapt std length (serial (b)(6)); sigrig, sig power sigrig reuse insertion guide (lot c2c7401x); sigtray, sig power sigtray sterilization tray (lot c9a6501).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 laparoscopic robotic low anterior resection, while creating the anastomosis, the stapler fired but did not complete the cut, leaving the tissue partially cut.Additionally, the screen showed a yellow exclamation mark above the reload swim lane the surgeon had to open the anastomosis and release the anvil from the stapled tissue, then resect the anastomosis and recreate another anastomosis using another reload with the same handle. the procedure was extended by 1 hour and 30 minutes.
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 reload connected to a signia circular adapter.The adapter trocar was noted to be extended to just beyond the distal surface of the reload.The staple pushers were noted to be flush with the surface of the reload.The second returned photo contained a view of the signia handle displaying green handle and adapter swim lanes and a yellow reload swim lane.The third returned photo contained a view of the anvil of the reload.The anvil was noted to be tilted and tissues was noted on the barrel of the anvil.The status of the cut could not be determined based on the image.Anvil.The received anvil was tilted and matched the reload.There was some visible damage to the anvil splines.The anvil cut ring was partially severed.It was reported that the stapler fired but did not complete the cut and the screen showed a yellow exclamation mark above the reload swim lane.The reported issues were 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: 24599148
• Report Number: 1219930-2026-01647
• Device Sequence Number: 9561090
• Product Code: GDW
• UDI-Device Identifier: 10884521703742
• UDI-Public: (01)10884521703742(17)280930(10)N5K1294UY
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/05/2026

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: 03/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 05/05/2026
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown