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

Model Number	SIGCIR28XT
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a robotic-assisted surgical (ras) sigmoid colectomy with colovesical fistula takedown, the spike would not properly connect to the anvil and the powered handle would not recognize that it was connected to measure the adaptive compression technology.The surgeon had to apply pressure to remove the anvil from the spike but could not successfully proceed to the next step on the screen.To resolve the issue, a new manual circular stapler was used.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant products: sigcirstnd, sigcirstnd signia circ adapt std length, (serial #: (b)(6)) sigphandle, sig power sigphandle handle, (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.
Additional Manufacturer Narrative
Additional information: b5, d1, d2 (product code, common device name), d3 (mfr name, street 1, mfr city, mfr region, postal code), d4 (model #, catalog #, expiration date, lot #, udi #), g3, g4 (pma / 510(k) #), h4 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 robotic-assisted surgical (ras) sigmoid colectomy with colovesical fistula takedown, the spike would not properly connect to the anvil and the powered handle would not recognize that it was connected to measure the adaptive compression technology.The surgeon had to apply pressure to remove the anvil from the spike but could not successfully proceed to the next step on the screen.To resolve the issue, a new manual circular stapler was used.It was noted that the handle work properly.There was no patient injury.

• Brand Name: TRI-STAPLE 2.0
• Common Device Name: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN SURGICAL; 60 middletown ave; north haven,ct PR 06473 4401
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven,ct PR 06473 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24636580
• Report Number: 2647580-2026-00740
• Device Sequence Number: 21079157
• Product Code: GAG
• UDI-Device Identifier: 10884521703735
• UDI-Public: (01)10884521703735(17)280831(10)N5J1408UY
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K221629
• 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): 03/27/2026

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: SIGCIR28XT
• Device Catalogue Number: SIGCIR28XT
• Device Lot Number: N5J1408UY
• 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: 02/24/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 09/09/2025
• 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 Age: 81 YR
• Patient Sex: Female