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

Model Number	SIG30AMT
Medical Device Problem Codes	Entrapment of Device (1212); Retraction Problem (1536); Difficult to Open or Close (2921); Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Laceration(s) (1946); Tissue Breakdown (2681)
Date of Event	06/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a robotic radical prostatectomy using the powered stapling system with an xl adapter and a reload, the knife blade was difficult to retract after firing while dividing the dorsal vein, and the jaws would not open while still on the tissue.The device was reported to be locked on the tissue and difficult to remove from the patient.The staple reload could not be opened, removed from the adapter, or unloaded.It was reported that the staple reload jaws were pulled off the tissue, resulting in tearing and tissue/skin damage or trauma to the dorsal vein.The procedure was reported to have been prolonged by approximately 30 minutes, and the patient was reported to be alive with injury.Troubleshooting steps were performed, including lifting up on the toggle, removing and reattaching the adapter, and resetting the power handle.A manual retraction tool was used in the center port of the adapter and turned clockwise.Resistance was felt on the first turn, after which no resistance was felt.It was reported that the tool did not retract the knife blade, and the top of the i-beam was not visible for tracking progress.The device was replaced, and the team transitioned to a robotic stapler after removing the powered stapling system.
Additional Manufacturer Narrative
D10 concomitant products: sigphandle, sig power sigphandle handle, (serial # (b)(6)); sigpshell, sig power sigpshell control shell, (lot # n5l1160y); sigadaptxl, sig power sigadaptxl linear xl adapter, (serial # (b)(6)); sigmret, sig power sigmret manual retract tool, (lot # c5j7401x).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.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: 25663687
• Report Number: 1219930-2026-04178
• Device Sequence Number: 10447243
• Product Code: GDW
• UDI-Device Identifier: 10884521543652
• UDI-Public: (01)10884521543652(17)301231(10)N6A1569Y(20)03
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: SIG30AMT
• Device Catalogue Number: SIG30AMT
• Device Lot Number: N6A1569Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/30/2026
• Date Device Manufactured: 01/30/2026
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown