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

Model Number	SIGTRSB60AMT
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: sigtrsb60amt, sigtrsb60amt 60mm med thk reinforced rel (lot # n4f1740y); sigphandle, sig power handle sigphandle-rfb (serial # (b)(6)); sigadaptxl, sig power sigadaptxl linear xl adapter (serial # (b)(6)); sigpshell, sig power sigpshell control shell (lot # unknown); sigtrsb60amt, sigtrsb60amt 60mm med thk reinforced rel (lot # n4f1617y); sigtrsb60amt, sigtrsb60amt 60mm med thk reinforced rel (lot n4g1995y); sigtrsb60amt, sigtrsb60amt 60mm med thk reinforced rel (lot # n4j1793y) 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 sleeve procedure, the reload component broke, specifically at the articulation joint, causing pieces to fall into the patient cavity.An x-ray was required to locate the components within the patient cavity.The pieces were successfully retrieved through a laparoscopic intervention.A scan was conducted on the patient as part of the procedure.The event resulted in an extended hospitalization for the patient.The product was returned without accompanying information.Medtronic's initial evaluation of the incident found that the blowout plate on the non-articulation flag side was returned disengaged from the reload.

• 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: 25155663
• Report Number: 1219930-2026-03160
• Device Sequence Number: 9324330
• Product Code: GDW
• UDI-Device Identifier: 10884521717626
• UDI-Public: (01)10884521717626(17)270630(10)N4G1995Y(20)04
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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: N4G1995Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown