MAUDE Adverse Event Report: COVIDIEN EEA; STAPLE, IMPLANTABLE

Model Number	TRIEEA21MT
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Cut (2587); Misassembly by Users (3133)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Tissue Breakdown (2681)
Date of Event	03/31/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: egia60amt, egia60amt egia 60 artic med thick sulu (lot# p5f1165s) egiaustnd, egiaustnd endogia ultra univ std stap (lot# 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.
Event or Problem Description
It was reported that during a laparoscopic radical resection for colon cancer involving transection of the right hemicolon and digestive tract reconstruction, a 60 mm manual linear purple stapler jammed mid firing.Moreover, a circular stapler was associated with poor staple formation and incomplete cutting after firing.An improperly matched instrument and anvil combination was used.Resection and re-stapling were performed to fix the staple line, and the stapler was replaced to re-anastomose and complete the case.An additional operation to correct the issue was reported.

• Brand Name: EEA
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 24889458
• Report Number: 2647580-2026-01053
• Device Sequence Number: 16034944
• Product Code: GDW
• UDI-Device Identifier: 10884521592988
• UDI-Public: (01)10884521592988(17)300531(10)P5F0972S(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K221771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2026

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: TRIEEA21MT
• Device Catalogue Number: TRIEEA21MT
• Device Lot Number: P5F0972S
• 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: 04/01/2026
• Initial Report FDA Received Date: 04/15/2026
• Date Device Manufactured: 06/11/2025
• 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 H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown