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

Model Number	SIG45CTAMT
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Retraction Problem (1536); Unintended Movement (3026); Noise, Audible (3273)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a robotic anterior segmentectomy with glisson en bloc resection, a power handle with a standard adapter and cartridge was in use when, during needle insertion, an abnormal mechanical noise was noted and the device articulated unintentionally, after which the knife failed to return and the jaws could not open or move forward or backward, resulting in tissue being clamped and unable to be released.Multiple troubleshooting steps were attempted intraoperatively, including restarting the handle, reconnecting components, calibration attempts, use of a manual adapter tool, and replacement of the handle and shell, all without resolution, leading to an extended operative time of approximately three hours, and ultimately the issue was resolved by applying a polymer locking ligation system on the patient side and dissecting the tissue with scissors, while the specimen side was divided using a monopolar instrument, allowing safe release of the tissue and completion of the procedure.The patient outcome was noted as prolonged operative time only, with the cartridge remaining connected to the adapter and planned for cleaning and sterilization, and subsequent evaluation suggesting a clip lodged in the tissue as a contributing factor.
Additional Manufacturer Narrative
D10 concomitant products: sigphandle, sig power sigphandle handle, (serial # (b)(6)) sigphandle, sig power sigphandle handle, (serial # (b)(6)) sigadaptstnd, sig power sigadaptstnd linear adapter, (serial # (b)(6)) sigpshell, sig power sigpshell control shell, (lot # n5e1579y) sigpshell, sig power sigpshell control shell, (lot # n5e1579y).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: d9, g3, h3, h6 correction: a2 and a3a should be blank h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the reload pushers were visible from the distal end of the cartridge and the jaws were open.The sled was visible between cut lines.There were scrapes observed on the i-beam.The returned reload came partially attached to the returned adapter.The proximal end of the reload adapter was broken and was lodged in the distal end of the adapter.Functional testing noted that the returned reload and adapter were connected to a handle.The reload was articulated towards pull and the reload was able to be released by pulling the blue unload button.The reload was removed.The broken reload adapter remained in the distal end of the returned adapter after the reload was removed.It was reported that the instrument experienced uncontrolled articulation, broke, and was difficult to retract.The knife blade made a strange noise, and the instrument became locked on the tissue.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.These issues may occur due to over flexure of the reload while attached to the instrument.The evaluation detected an unreported condition: the device partially fired.The product analysis noted evidence that the device was not used as intended.This issue may occur if the user presses the open key prior to the i-beam reaching the end of the reload.Following retraction, the safety interlock feature will engage and prevent the reload from firing a second time.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: 24220039
• Report Number: 1219930-2026-00589
• Device Sequence Number: 21141726
• Product Code: GDW
• UDI-Device Identifier: 10884521543713
• UDI-Public: (01)10884521543713(17)300131(10)N5B1544Y(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): 04/24/2026

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: SIG45CTAMT
• Device Catalogue Number: SIG45CTAMT
• Device Lot Number: N5B1544Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 04/24/2026
• 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 Age: 73 YR
• Patient Sex: Male