MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	SIG30CTAV
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Insufficient Information (4580)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant medical products: egia60amt, egia60amt egia 60 artic med thick sulu (lot#:p4g0994), sig60ctamt, tri 2.0 sig60ctamt 60 ct med thk 12mm (lot#:n4b1706y), sig60ctamt, tri 2.0 sig60ctamt 60 ct med thk 12mm (lot#:n3f0383y), sig30ctav, tri 2.0 sig30ctav 30 ct vsclr 12mm (lot#:n4e1903y), sig45ctamt, tri 2.0 sig45ctamt 45 ct med thk 12mm (lot#:n4f2017y), sig60ctamt, tri 2.0 sig60ctamt 60 ct med thk 12mm (lot#:n3f0383y), sig30ctav, tri 2.0 sig30ctav 30 ct vsclr 12mm (lot#:n4e1903y) 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
According to the reporter during a thoracoscopic lobectomy (upper lobe, lower lobe), after the firing there was leak from the staple line, it was a minor anastomotic leak.Confirmation using air bubbles/methylene blue.The leak site was sutured during the suturing, there were moments when the lung was avoided.
Event or Problem Description
According to the reporter, during a thoracoscopic lobectomy (upper lobe, lower lobe), after the firing, there was a leak from the staple line; it was a minor anastomotic leak.Confirmation using air bubbles/methylene blue. the leak site was sutured, and during the suturing, there were moments when the lung was avoided.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements in 21 cfr 803.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 LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21090560
• Report Number: 1219930-2025-00106
• Device Sequence Number: 9171757
• Product Code: GDW
• UDI-Device Identifier: 10884521543737
• UDI-Public: 10884521543737
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: SIG30CTAV
• Device Catalogue Number: SIG30CTAV
• Device Lot Number: N4E1903Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/10/2024
• 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.
• Patient Sex: Unknown