MAUDE Adverse Event Report: Covidien EEA; STAPLER, SURGICAL

Model Number	TRIEEA31MT
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Abscess (1690)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a low anterior resection, the circular stapler cut without stapling.A new circular stapler was used to resolve the issue.Due to the issue, the patient extended the hospital stay for two more days and the patient had an antibiotic while there was an abscess at the site of the stapler due to stool observation after the stapler failure.
Additional Manufacturer Narrative
Additional information: a2, b2, b5, g3, h1, h6 new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.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: 50459043
• Report Number: 2647580-2026-02563
• Device Sequence Number: 9972568
• Product Code: GAG
• UDI-Device Identifier: 10884521593046
• UDI-Public: (01)10884521593046(17)290430(10)P4E0848
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K221005
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/22/2026

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: TRIEEA31MT
• Device Catalogue Number: TRIEEA31MT
• Device Lot Number: P4E0848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Supplement Date Received by Manufacturer: 09/20/2026; 09/15/2026; 09/20/2026
• Initial Report FDA Received Date: 08/26/2026
• Supplement Report FDA Received Date: 09/21/2026; 09/22/2026; 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Unknown