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

Model Number	SIG60CTAMT
Medical Device Problem Codes	Difficult to Open or Close (2921); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: sigphandle, sig power sigphandle handle (serial#:unknown), sigadaptstnd, sig power sigadaptstnd linear adapter (serial#:unknown), sigpshell, sig power sigpshell control shell (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.
Event or Problem Description
According to the reporter during a robot-assisted pancreaticoduodenectomy, the cartridge was connected and tried to fire, but the green button did not light up and the firing could not be done.When the cartridge was taken out from the outside surgical field, the jaw could not be opened.The nurse managed to detach it from the adapter and connected another cartridge and it was able to be used without any problems.There was no patient injury.
Additional Manufacturer Narrative
Additional information: g3, 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 reload was pre-fired and the interlock was engaged.Staples were protruding from the proximal end of the staple cartridge channel.The sled was slightly advanced.I beam was slightly advanced and the jaw of the reload was closed.It was reported that during the robot-assisted pancreaticoduodenectomy, the cartridge was connected and tried to fire, but the green button did not light up and the firing could not be done.When the cartridge was taken out from the outside surgical field, the jaw could not be opened.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the instrument firing handle had been partially compressed and released after pressing the green firing button.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: ensure that the black return knob on the instrument is pulled back completely and the articulation lever is neutral (0° relative) to the instrument.Cycle the instrument to confirm proper loading of the reload.To do so, squeeze the handle once to close the jaws of the reload.Push the black loop handle all of the way forward or pull back on the black return knob and confirm that the reload jaws open fully.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.Shipping wedge printing.Do not remove until loaded.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: 23541454
• Report Number: 1219930-2025-05287
• Device Sequence Number: 13092030
• Product Code: GDW
• UDI-Device Identifier: 10884521543683
• UDI-Public: (01)10884521543683(17)300131(10)N5B1545Y(20)03
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2026

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: SIG60CTAMT
• Device Catalogue Number: SIG60CTAMT
• Device Lot Number: N5B1545Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 01/02/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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