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

Model Number	SIGTRSB45AXT
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10.Concomitant products: sigtrsb45axt, sigtrsb45axt 45mm xtr thk reinforced rel (lot n4d2063y).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 robotic laparoscopic sleeve gastrectomy, there was an incomplete staple line at the distal end while stapling the stomach.This issue occurred on two reloads.Different reloads were used to complete the firing and resolve the issue.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the returned photo contained a view of two staple lines.No staples were missing from the visible staple lines.Functionally, the reload was loaded onto a representative handle.The handle recognized the reload as used.The reload was loaded into a manual handle.The interlock was overridden and the reload was applied to test media.All remaining staples were placed, test media was cleanly transected and the distal sutures were released.The reload interlock was tested and found to function properly.It was reported that there was a staple line was incomplete.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.The evaluation detected an unreported condition: device partially fired.Visually, the reload was partially fired with the interlock engaged.The jaws were open.Staple pushers were visible at the 2cm cut line.Staple pushers were sub-flush to flush with the cartridge.The distal suture on the anvil and cartridge side were still anchored.The reinforcement material was torn and/or missing on the cartridge and anvil side of the jaws.The clamping mechanism was deformed.The product analysis noted evidence that the device was not used as intended.The partial fire condition with interlock engagement may occur when the firing handle has not been completely cycled.If the instrument return knobs are retracted at any point once the firing cycle has begun, the reload will engage into safety interlock and prevent further attempts to fire by ceasing the placement of staples and tissue transection and prevent patient harm.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: failure to completely fire the reload will result in an incomplete cut and/or incomplete staple formation, which may result in poor hemostasis and/or leakage.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: 22583411
• Report Number: 1219930-2025-03189
• Device Sequence Number: 13134715
• Product Code: GDW
• UDI-Device Identifier: 10884521717619
• UDI-Public: (01)10884521717619(17)270331(10)N4D2063Y(20)04
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: SIGTRSB45AXT
• Device Catalogue Number: SIGTRSB45AXT
• Device Lot Number: N4D2063Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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