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

Model Number	SIGC60MT
Medical Device Problem Codes	Misfire (2532); Failure to Form Staple (2579); Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: siglu60a; tri 2.0 siglu60a 60 load unit; (lot number: n3h2068y) siglu60a; tri 2.0 siglu60a 60 load unit; (lot number: n3h2068y) sigc60mt; tri 2.0 sigc60mt 60 med thk cartridge; (lot number: n3e0065y) sigc60mt; tri 2.0 sigc60mt 60 med thk cartridge; (lot number: n3e0065y) sigphandle; sig power sigphandle handle; (serial number: unknown) sigadaptxl; sig power sigadaptxl linear xl adapter; (serial number: 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.
Event or Problem Description
It was reported that during a surgical procedure using the loading units and reloads with a powered stapler and xl adapter, the reloads were not able to form proper b staples, staples that opened and could not close fully, staples fell into the abdominal cavity, reloads were not able to fire fully, incomplete staple lines, and the device not being able to fire even with new blades and reloads which resulted to extended surgical time of two hours due to multiple device issues.It was confirmed that the staples were retrieved by hand instruments.Troubleshooting involved replacing the device with new blades and reloads, but the same issues persisted, leading to the use of staplers from another company.
Additional Manufacturer Narrative
Additional information: d9, g3, h2, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the cartridge shield on the proximal end of the cartridge assembly (opposite the cartridge connecter chip) was detached from the proximal end of the cartridge assembly.The proximal end of the cartridge assembly (where the cartridge shield attaches to the cartridge assembly) was found to be damaged at the proximal end of the tri-staple 2.0 cartridge assembly.The cartridge connector chip was disengaged.The staple cartridge was partially fired.Staple pushers were visible at the 4cm cut line.Functional testing was withheld to maintain the state.It was reported that component disengaged, instrument did not fire, partial firing and staples poorly formed.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.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 loading unit/cartridge 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: 24242765
• Report Number: 1219930-2026-00637
• Device Sequence Number: 9618251
• Product Code: GDW
• UDI-Device Identifier: 10884521543584
• UDI-Public: (01)10884521543584(17)280430(10)N3E0065Y(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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: SIGC60MT
• Device Catalogue Number: SIGC60MT
• Device Lot Number: N3E0065Y
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2023
• 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 COMMENT ON H11.
• Patient Sex: Female