MAUDE Adverse Event Report: COVIDIEN SURGICAL TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	SIGCIR28MT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Tissue Breakdown (2681); High White Blood Cell Count (4594)
Date of Event	08/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, six days post-operative of a sigmoid colectomy where a powered circular stapler was used to create anasto mosis, the white blood cells of the patient elevated from 9 to 14.7.A computed tomography (ct) scan of the abdomen and pelvis with intravenous (iv) and rectal contrast showed that the patient had leak at the colorectal anastomosis.The patient was taken to the operating room and the anterior portion of the anastomosis had dehisced.The dehisced portion was resected and a colostomy was brought up.The patient was brought to the intensive care unit post-operatively.The patient's hospitalization was extended 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.
Event or Problem Description
According to the reporter, six days post-operative of a sigmoid colectomy performed on (b)(6)2025, where a powered circular stapler was used to create anastomosis, the white blood cells of the patient elevated from 9 to 14.7.A computed tomography (ct) scan of the abdomen and pelvis with intravenous (iv) and rectal contrast showed that the patient had leak at the colorectal anastomosis.The patient was taken to the operating room and the anterior portion of the anastomosis had dehisced.The dehisced portion was resected and a colostomy was brought up.The patient was brought to the intensive care unit post-operatively.The patient's hospitalization was extended for five days as a result.
Additional Manufacturer Narrative
Additional information: b3, b5, g3, h6.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: TRI-STAPLE 2.0
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 22790458
• Report Number: 1219930-2025-03540
• Device Sequence Number: 8789139
• Product Code: GDW
• UDI-Device Identifier: 10884521703728
• UDI-Public: 10884521703728
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: SIGCIR28MT
• Device Catalogue Number: SIGCIR28MT
• Device Lot Number: N5D1681UY
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 10/30/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 93 KG