MAUDE Adverse Event Report: Covidien Tri-Staple 2.0; STAPLE, IMPLANTABLE

Model Number	SIG45AVM
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laparoscopic ileostomy takedown, when the stapler was fired across the small bowel and stopped approximately halfway through firing, about 15 mm in, and would not re-engage or fire again.The reload was removed and replaced with another 45 mm tan reload using the same powered stapler handle and sterile shell.The replacement reload functioned properly, and the procedure continued.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
D10 concomitant products : sigpshell - sig power sigpshell control shell - lot# n5j1737y sigphandle - sig power sigphandle handle - lot# c25aah0276 sigadaptstnd - sig power sigadaptstnd linear adapter - lot# unknown 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; sabanetas industrial park; ponce PR 00716 -440
• Manufacturer (Section G): Covidien; sabanetas industrial park; ponce PR 00716 -440
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50466457
• Report Number: 2647580-2026-02574
• Device Sequence Number: 13301172
• Product Code: GDW
• UDI-Device Identifier: 10884521808966
• UDI-Public: (01)10884521808966(17)301231(10)P6A1015(20)01
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K202864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: SIG45AVM
• Device Catalogue Number: SIG45AVM
• Device Lot Number: P6A1015
• 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: 08/10/2026
• Initial Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 01/20/2026
• 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 Age: 65 YR
• Patient Sex: Male