MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN TRI-STAPLE 2.0; STAPLE, IMPLANTABLE

Model Number	SIGTRSB45AXT
Medical Device Problem Codes	Break (1069); Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: sigphandle, sig power sigphandle handle; sigadaptshort, sig power sigadaptshort lin short adapt; sigpshell, sig power sigpshell control shell 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, in a partial pulmonary resection, while in the pulmonary parenchyma, a reinforced reload was used.As the knife blade was being advanced to the tip, when one additional push was made, the articulation part was unintentionally greatly bent.The part inside the articulation part was damaged.No device component fell into the patient¿s cavity.There was no patient injury.
Additional Manufacturer Narrative
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 fully fired and the interlock was engaged.The jaw of the reload was open.The sutures were cut properly.One side of the articulating point was broken.Functional testing noted that the reload was loaded into a representative handle.The interlock was overridden and the reload was applied to test media.Test media was transected.The reload interlock was tested and found to function properly.It was reported that the instrument was articulating or straightening during firing.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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 LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21930001
• Report Number: 1219930-2025-02013
• Device Sequence Number: 8715166
• Product Code: GDW
• UDI-Device Identifier: 10884521717619
• UDI-Public: (01)10884521717619(17)270930(10)N4K1612Y(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173270
• 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): 07/11/2025

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: SIGTRSB45AXT
• Device Catalogue Number: SIGTRSB45AXT
• Device Lot Number: N4K1612Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2024
• 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
• Patient Sex: Unknown