MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	EEA31
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Fistula (1862); Organ Dehiscence (2502); Tissue Breakdown (2681)
Date of Event	05/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the patient underwent a left hemicolectomy for sigmoid neoformation on (b)(6) 2026.The procedure included rectal transection with a single firing of a 60 mm purple reload and a colorectal anastomosis performed according to the knight-griffen technique using a 31 mm circular stapler.A pneumatic leak test was negative, and 90 seconds of precompression were performed.On (b)(6) 2026, the patient underwent reintervention for an early anastomotic fistula.Intraoperative findings showed partial dehiscence of the anterior wall, with staples appearing partially open, suggestive of incomplete or incorrect closure.
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 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 25680294
• Report Number: 2647580-2026-01960
• Device Sequence Number: 9722198
• Product Code: GAG
• UDI-Device Identifier: 10884523005554
• UDI-Public: 10884523005554
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K221003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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: EEA31
• Device Catalogue Number: EEA31
• 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: 06/25/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 07/16/2026
• 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: 45 YR
• Patient Sex: Female