MAUDE Adverse Event Report: US SURGICAL PUERTO RICO EEA; STAPLER, SURGICAL

Model Number	TRIEEAXL31MT
Medical Device Problem Codes	Break (1069); Device Slipped (1584); Failure to Form Staple (2579)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Tissue Breakdown (2681)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a low left colon resection involving the circular stapler, the safety lever of the stapler was broken likely due to incomplete closing caused by the presence of excessive tissue.Although the blade worked, but the stitches were being shot open, the staples were not formed b shaped but a bit linear.Suturing was performed as a replacement for the staple line.A protective stoma creation was necessary.The surgical time was extended for one hour 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): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21128392
• Report Number: 2647580-2025-00177
• Device Sequence Number: 6829812
• Product Code: GAG
• UDI-Device Identifier: 10884521593145
• UDI-Public: 10884521593145
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2025

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: TRIEEAXL31MT
• Device Catalogue Number: TRIEEAXL31MT
• Device Lot Number: P3A0190
• 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: 12/19/2024
• Initial Report FDA Received Date: 01/10/2025
• Date Device Manufactured: 01/18/2023
• 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 Sex: Female