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

Model Number	SIGTRSB60AXT
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparoscopic sleeve gastrectomy, the handles broke and cracked.The surgeon attempted multiple reloads and went from purple to black on the antrum of the stomach, yet the surgeon could not fire through one area of the stomach; it was partially fired.After multiple attempts, the surgeon moved lateral and completed the sleeve with no issues.The surgeon oversewed the staple line at the area.
Additional Manufacturer Narrative
D10 concomitant products: egiauxl, egiauxl endogia ultra univ xl stapler, (lot number: p5j1186) egiauxl, egiauxl endogia ultra univ xl stapler, (lot number: p4a0996) sigtrsb60amt, sigtrsb60amt 60mm med thk reinforced rel, (lot number: n3c0810y) sigtrsb60axt, sigtrsb60axt 60mm xtr thk reinforced rel, (lot number: n5j1450y) sigtrsb60amt, sigtrsb60amt 60mm med thk reinforced rel, (lot number: n3c0810y) sigtrsb60axt, sigtrsb60axt 60mm xtr thk reinforced rel, (lot number: n5j1450y) egia45amt, egia45amt egia 45 artic med thick sulu, (lot number: 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.

• 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: 24372947
• Report Number: 1219930-2026-01049
• Device Sequence Number: 20246345
• Product Code: GDW
• UDI-Device Identifier: 10884521717633
• UDI-Public: (01)10884521717633(17)280831(10)N5J1450Y(20)04
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173270
• 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
• Report Date (Section B): 02/17/2026

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: SIGTRSB60AXT
• Device Catalogue Number: SIGTRSB60AXT
• Device Lot Number: N5J1450Y
• 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: 01/27/2026
• Initial Report FDA Received Date: 02/17/2026
• Date Device Manufactured: 09/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 43 YR
• Patient Sex: Male