MAUDE Adverse Event Report: Covidien EEA; STAPLER, SURGICAL

Model Number	TRIEEA28MT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Wound Dehiscence (1154); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Unintended Radiation Exposure (4565); High White Blood Cell Count (4594); Blood Protein Abnormal (4595)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, post-operatively of a procedure in (b)(6) 2026 where a circular stapler was used, the patient had elevated leukocyte but was in good spirits.The next day, leukocyte counts rose further, c-reactive protein (crp) was high, and the patient experienced pain and bleeding.The next day, when the surgeon viewed the ct scan, a large mass was visible, prompting a decision to reoperate the patient.Upon lifting the colon during reoperation, the anastomosis was observed to be open.The patient had an early anastomotic dehiscence involving 70¿80% of the anastomosis circumference.Consequently, the surgeon decided to transect the colon and create a temporary ileostomy.The surgeon noted that the descended colon was viable, well-perfused, and tension-free, and that there was a dissecting hematoma in the wall.The patient¿s hospital stay was extended as a result.
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: EEA
• Common Device Name: STAPLER, SURGICAL
• Manufacturer (Section D): Covidien; sabanetas industrial park; ponce PR 00716 -440
• Manufacturer (Section G): Covidien; sabanetas industrial park; ponce PR 00716 -440
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50303567
• Report Number: 2647580-2026-02412
• Device Sequence Number: 10135339
• Product Code: GAG
• UDI-Device Identifier: 10884521593022
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K172361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: TRIEEA28MT
• Device Catalogue Number: TRIEEA28MT
• Device Lot Number: P6C0685
• 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: 07/24/2026
• Initial Report FDA Received Date: 08/18/2026
• Date Device Manufactured: 03/04/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male