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

Model Number	SIGTRSB45AMT
Medical Device Problem Codes	Break (1069); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: sigphandle, sig power sigphandle handle (lot#unknown); sigadaptstnd, sig power sigadaptstnd linear adapter (lot#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 during use, the reload was difficult to fire when used with a powered handle and standard adapter.The device was replaced with a new reload to resolve the issue.No patient complications have been reported as a result of this event.Medtronic's initial evaluation of the incident device found that the jaws were open.
Additional Manufacturer Narrative
Correction:e1 (phone number) additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the reload was partially fired.Pushers were visible up to the 2.5cm cut line.The jaws were open.Staple pushers were flush with the cartridge.The remaining buttress material had been cut and was still attached to the reload distally.It was reported that during use, the reload was difficult to fire when used with a powered handle and standard adapter.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when firing over tissue that is beyond the recommended thickness.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: do not use on tissue that does not easily compress to 1.2 mm-1.95 mm.Do not use on tissue that does not easily compress to 1.95 mm-2.7 mm.Use of this product in applications other than those indicated has the potential for serious complications, such as inadequate reinforcement strength, staple pullout, infection, abrasion, migration and erosion.When positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.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: 24638038
• Report Number: 1219930-2026-01754
• Device Sequence Number: 21374604
• Product Code: GDW
• UDI-Device Identifier: 10884521717602
• UDI-Public: (01)10884521717602(17)270430(10)N4E2099Y(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIGTRSB45AMT
• Device Catalogue Number: SIGTRSB45AMT
• Device Lot Number: N4E2099Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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: PLEASE SEE NOTE ON H11.
• Patient Sex: Unknown