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); Fever (1858); Unspecified Infection (1930); Unintended Radiation Exposure (4565)
Date of Event	06/15/2026
Type of Reportable Event	Serious Injury
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
It was reported that, following a benign procedure for diverticulitis, a patient with a medical history of diverticulitis and cardiovascular disease and prior abdominal and colorectal surgeries developed an anastomotic leak.Post-procedure, the patient had a fever of 101.5°f on post-operative day 5 with a peri-anastomotic gas collection measuring 3.5 × 3.5 cm.Computed tomography (ct scan) of the abdomen and pelvis with intravenous contrast was performed and surgery confirmed a small anastomotic defect consistent with a grade c anastomotic leak requiring operative intervention.The event was serious and involved prolongation of an existing hospitalization.The patient underwent diagnostic laparoscopy with diverting loop ileostomy, and medication changes were reported.The investigator and sponsor assessed the event as having a causal relationship to the study procedure and as possibly related to the study device.

• 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: 25578637
• Report Number: 1219930-2026-03948
• Device Sequence Number: 17431846
• Product Code: GDW
• UDI-Device Identifier: 10884521703728
• UDI-Public: (01)10884521703728(17)290228(10)N6A1415UY(20)01
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: SIGCIR28MT
• Device Catalogue Number: SIGCIR28MT
• Device Lot Number: N6A1415UY
• 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: 06/19/2026
• Initial Report FDA Received Date: 06/22/2026
• Date Device Manufactured: 03/11/2026
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American