MAUDE Adverse Event Report: Covidien EEA; STAPLE, IMPLANTABLE

Model Number	TRIEEA21MT
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Tissue Breakdown (2681)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction

• Brand Name: EEA
• Common Device Name: STAPLE, IMPLANTABLE
• 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: 50496258
• Report Number: 2647580-2026-02597
• Device Sequence Number: 18698072
• Product Code: GDW
• UDI-Device Identifier: 10884521592988
• UDI-Public: (01)10884521592988(17)290731(10)P4H1203(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

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: TRIEEA21MT
• Device Catalogue Number: TRIEEA21MT
• Device Lot Number: P4H1203
• 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: 08/19/2026
• Initial Report FDA Received Date: 08/28/2026
• Date Device Manufactured: 08/28/2024
• 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
• Patient Sex: Unknown