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

Model Number	SIGCIR31MT
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10.Concomitant products: sigcirxl sigcirxl signia circ adapt x lng length - (serial# (b)(6)); sigphandle sig power sigphandle handle - (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
According to the reporter, during a robotic laparoscopic sigmoidectomy, after the powered circular stapler completed its stapling and following firing sequence and before tapping up on the toggle, yellow swim lanes two for adapter and three for reload turned yellow with a warning triangle.The stapler prompted the surgeon to open the spike, and nothing happened, but the spike was fully extended.The surgeon extended the spike and the middle yellow swimlane turned green but the last yellow swim lane remained yellow.The surgeon proceeded to pull the stapler out, and it came out without the anvil connected to the spike.The surgeon had to manually pull the anvil from the patient's rectum.Upon inspection, donuts were complete, and the leak test was negative.The surgical time was extended by 25 minutes.There was no patient injury.
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.The electronic device-use logs were also provided.Visual inspection noted a signia sigcir31mt reload connected to a signia circular adapter was visible.The adapter trocar was extended.Visual inspection of the returned device noted that the received anvil was tilted and matched the reload.There was no noted damage on the grasping notch and anvil splines.The anvil cut ring was only partially severed, with evidence of knife impact only visible on half of the cut ring.The reload instrument was fully fired.The pushers were visible at the surface of the cartridge.The knife blade showed signs of normal use.A review of the system logs showed the reload was connected to gen ii acc.The data saved to the reload showed: a max clamp force of 171, the max staple force was 430 and max cut force was 350.It was reported that the anvil disengaged.The reported issue could not be confirmed.The most likely cause could not be established from the information available.It was also reported that the reload had a yellow swim lane.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: the distance between the staple line and the piercing point of the trocar should be close enough to ensure transection of the staple line, but far enough to allow easy passage of the center rod of the anvil/center rod assembly through the distal bowel during approximation.Prior to introduction of the stapler, place pursestring sutures no more than 2.5 mm from the cut edge of the tissue to avoid grasping excessive tissue within the closed anvil and cartridge.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: 24557888
• Report Number: 1219930-2026-01563
• Device Sequence Number: 9331184
• Product Code: GDW
• UDI-Device Identifier: 10884521703742
• UDI-Public: (01)10884521703742(17)280831(10)N5J1301UY
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/29/2026

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: N5J1301UY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2026
• 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: 05/28/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• 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
• Patient Sex: Female
• Patient Weight: 64 KG