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

Model Number	SIGCIR28XT
Medical Device Problem Codes	Misfire (2532); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Laceration(s) (1946); Tissue Breakdown (2681)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the colostomy takedown robotic procedure, a multiple holes were made in the small bowel and repaired during the procedure.At the time of the anastomosis, the circular stapler sizers could not reach the end of the rectal stump, and the circular stapler was applied regardless.The resident robotically held up each corner of the rectal stump, resulting in holes being ripped in the corners of the rectum.The surgeon extended the spike through one of the holes and fired the circular stapler, which produced an incomplete donut on the anvil side and a thin donut on the circular side.The surgeon inspected the small bowel and performed a leak test, which failed, indicating anastomotic leakage.The procedure was converted from robotic laparoscopic to open, and the surgeon sutured the hole closed, performed a loop ileostomy, and conducted a small bowel resection.Extended surgical time was noted.
Additional Manufacturer Narrative
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: 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: 24552461
• Report Number: 1219930-2026-01546
• Device Sequence Number: 5662307
• Product Code: GAG
• UDI-Device Identifier: 10884521703735
• UDI-Public: (01)10884521703735(17)280831(10)N5J1409UY
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 03/09/2026

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: SIGCIR28XT
• Device Catalogue Number: SIGCIR28XT
• Device Lot Number: N5J1409UY
• 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: 02/17/2026
• Initial Report FDA Received Date: 03/09/2026
• Date Device Manufactured: 09/12/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown