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

Model Number	SIGCIR28MT
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, in a laparoscopic robot assisted lower anterior resection, the procedure began with a 28 mm purple reload.The compression achieved was 100% in zone 3, but in pursuit of optimal stapling results, the surgeon elected to switch to a black 28 mm reload.The anvil from the original purple 28 mm reload was retained for use.Upon closing the anvil, an obstruction alert was triggered.During unclamping, it was noted that the anvil had tilted.Due to concerns regarding proceeding with a tilted anvil, the surgeon opted to replace it with the anvil from the black 28 mm reload.Compression was then achieved at 100% in zone 2 and stapling was completed successfully with the black 28 mm.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant products: sigcir28xt, ts 2.0 sigcir28xt circ.28mm xtr thick, (lot # n5d1578uy).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: 22684094
• Report Number: 1219930-2025-03405
• Device Sequence Number: 8936849
• Product Code: GDW
• UDI-Device Identifier: 10884521703728
• UDI-Public: 10884521703728
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182475
• 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): 08/01/2025

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: SIGCIR28MT
• Device Catalogue Number: SIGCIR28MT
• Device Lot Number: N5D1681UY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/01/2025
• 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
• Patient Sex: Unknown