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

Model Number	SIGCIR28MT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Diarrhea (1811); Perforation (2001); Tachycardia (2095); Confusion/ Disorientation (2553); Unintended Radiation Exposure (4565)
Date of Event	01/21/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that no device issues with the powered circular stapler were reported during the laparoscopic low anterior resection; however, postoperatively, a patient experienced a perforation in the rectum several days after surgery, as well as anastomotic leakage.The patient was readmitted to the hospital and subsequently admitted to the intensive care unit.An additional surgical procedure was performed as treatment.The patient's prognosis was not good, leading the family to decide that the ventilator be taken off the patient.The patient passed away.
Additional Manufacturer Narrative
D10 concomitant product: sigphandle, sig power sigphandle handle (serial#: 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.
Additional Manufacturer Narrative
Additional information: b5, e1, e3, g3, h3, h6.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 no device issues with the powered circular stapler were reported during the laparoscopic low anterior resection; the patient was readmitted four to five days later due to confusion, elevated heart rate, and diarrhea.Computed tomography (ct) scans were done to see if there was fluid build up in the pelvis near anastomosis.Fluid tests were also done to see if liquid contained bowel contents.Minor fluid buildup was observed in the pelvis and fluid tests were running clear without bowel contents.The patient was continued to be monitored to ensure stability, and a second round of the same tests were performed, which came back showing more significant build up of fluid in the pelvis.It was then decided that emergent re-operation was needed, where perforation in the rectum and anastomotic leakage was confirmed.Closure of the perforation was performed.The patient was subsequently admitted to the intensive care unit.The patient's prognosis was not good, leading the family to decide that the ventilator be taken off the patient.The patient passed away.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The involved device was not returned.However, a video was provided.Visual inspection showed the inside of a patient through a scope.Graspers were used to manipulate the colon.No leaks could be seen in the video.It was reported that there was staple line content leak.The reported issue could not be 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.A secondary review of the device history records found no potentially contributing factors.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: 24387400
• Report Number: 1219930-2026-01149
• Device Sequence Number: 10622191
• Product Code: GDW
• UDI-Device Identifier: 10884521703728
• UDI-Public: (01)10884521703728(17)280930(10)N5K1404UY
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIGCIR28MT
• Device Catalogue Number: SIGCIR28MT
• Device Lot Number: N5K1404UY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 02/11/2026; 04/21/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/02/2026; 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2025
• 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 NOTE ON H11.
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization; Death
• Patient Sex: Unknown