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

Model Number	SIGTRSB60AMT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Tissue Breakdown (2681)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10.Concomitant products: egia60amt, egia60amt egia 60 artic med thick sulu (lot p5g1125); egia60avm, egia60avm egia 60 artic vasc med sulu (lot p4b0827); sig60ctavm, tri 2.0 sig60ctavm 60 ct vsclr med 12mm (lot n5c1845y) 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 during a laparoscopic adjustable gastric band and subcutaneous port removal, as well as a laparoscopic partial gastrectomy roux-en-y with intraoperative endoscopy, staple line bleeding was observed from the remnant stomach after 20 minutes offiring a purple reinforcement reload.The same issue occurred on another purple reload.Additionally, from the staple line at the jejunum after 20 minutes of firing a curved tip tan load, the same issue occurred.Suturing was performed as a staple line reinforcement to resolve the issue.It was noted that the surgical procedure was extended by about 30 minutes.
Event or Problem Description
It was reported that during a laparoscopic adjustable gastric band and subcutaneous port removal, as well as a laparoscopic partial gastrectomy roux-en-y with intraoperative endoscopy, after firing the purple reload, bleeding occurred.When the remnant stomach was created, after 15 minutes of firing a purple reinforcement reload, there was staple line bleeding.Additionally, from the staple line at the jejunum after 20 minutes of firing a curved tip tan load, the same issue occurred.Suturing was performed as a staple line reinforcement to resolve the issue.It was noted that the surgical procedure was extended by about 30 minutes.
Additional Manufacturer Narrative
Additional information: b5, g3 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: 24848370
• Report Number: 1219930-2026-02373
• Device Sequence Number: 15690100
• Product Code: GDW
• UDI-Device Identifier: 10884521717626
• UDI-Public: (01)10884521717626(17)280531(10)N5F1652Y(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,Followup,Followup
• Report Date (Section B): 06/26/2026

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: SIGTRSB60AMT
• Device Catalogue Number: SIGTRSB60AMT
• Device Lot Number: N5F1652Y
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 06/25/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 04/15/2026; 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 98 KG