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

Model Number	SIG60AXT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Laceration(s) (1946); Sepsis (2067)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: sig60axt, tri 2.0 sig60axt 60 xtra thk 15mm (lot#: n2f0061y) sig60axt, tri 2.0 sig60axt 60 xtra thk 15mm (lot#: n2j0231y) sigpshell, sig power sigpshell control shell (lot#: unknown) sigphandle, sig power sigphandle handle (serial#: 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 20 days post-operatively on an open bowel resection, the patient was readmitted to the hospital with infection and was septic due to the staple line not holding on the rectal stump.Three reloads were used and had the same issue.An open repair of rectal stump dehiscence and open repair of colotomy were performed, and suturing was performed as a staple line replacement.An antibiotic was also provided for the treatment of sepsis and the patient was admitted in the intensive care unit (icu) after procedure.
Event or Problem Description
It was reported that 20 days post-operatively on an open bowel resection, the patient was readmitted to the hospital with infection and was septic due to the staple line not holding on the rectal stump.Three reloads were used and had the same issue.An open repair of rectal stump dehiscence and open repair of colotomy were performed, and suturing was performed as a staple line replacement.An antibiotic was also provided for the treatment of sepsis and the patient was admitted in the intensive care unit (icu) after procedure for seven days.
Additional Manufacturer Narrative
Correction: b5 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: 25021704
• Report Number: 1219930-2026-02804
• Device Sequence Number: 21406210
• Product Code: GDW
• UDI-Device Identifier: 10884521543591
• UDI-Public: (01)10884521543591(17)270531(10)N2F0061Y
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160176
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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: SIG60AXT
• Device Catalogue Number: SIG60AXT
• Device Lot Number: N2F0061Y
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 06/03/2022
• 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 NOTE ON H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown