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

Model Number	SIG60AXT
Medical Device Problem Codes	Misfire (2532); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Laceration(s) (1946); Pain (1994)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10: concomitant products: sigphandle, sig power sigphandle handle (serial # (b)(6)); sigadaptstnd, sig power sigadaptstnd linear adapter (serial # (b)(6)).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 pleuroscopy for pneumothorax cure procedure, the handle was force; the stapling process did not complete all the way, and the handle subsequently got locked and broke.The two 60mm reloads failed under pressure.Under these circumstances, the procedure was converted, a short posterolateral thoracotomy is performed through the 4th intercostal space.The atypical excision of the pulmonary lesion is completed using cold scissors.Hemostasis is achieved using interrupted cross-stitches with 4-0 suture from another manufacturer.An air-leak test is performed, revealing moderate bubbling in the areas where the pleura had been stripped.Several long running 3-0 sutures are placed to cover all areas potentially responsible for the air leak.No notable complications regarding the operative site occurred during the hospital stay.The chest drain was removed on day 4.Follow-up chest x-rays demonstrated resolution of the pneumothorax, with no additional pathological findings.Pain was controlled with analgesics.The patient remained afebrile throughout hospitalization.

• 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--439 ; 8006464633
• MDR Report Key: 24679299
• Report Number: 1219930-2026-01938
• Device Sequence Number: 9653215
• Product Code: GDW
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SIG60AXT
• Device Catalogue Number: SIG60AXT
• Device Lot Number: N5H1238Y
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 06/03/2026; 06/26/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 06/18/2026; 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2025
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male