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

Model Number	SIG30CTAV
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant medical products: sig30ctavm, tri 2.0 sig30ctav 30 ct vsclr 12mm, (lot# unknown) sig45ctamt, tri 2.0 sig45ctamt 45 ct med thk 12mm, (lot# unknown) sig60ctamt, tri 2.0 sig60ctamt 60 ct med thk 12mm, (lot# unknown) egia60amt, egia60amt egia 60 artic med thick sulu, (lot# unknown) sig30ctav, tri 2.0 sig30ctav 30 ct vsclr 12mm, (lot# unknown) sig30ctav, tri 2.0 sig30ctav 30 ct vsclr 12mm, (lot# unknown) sig45ctamt, tri 2.0 sig45ctamt 45 ct med thk 12mm, (lot# unknown) sig45ctamt, tri 2.0 sig45ctamt 45 ct med thk 12mm, (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 pulmonary resection, the shipping wedge broke.There was no patient injury.
Event or Problem Description
According to the reporter, during a pulmonary resection, two out of the three small pieces came out in the form of splinters near the protrusion of the yellow tab, and were taken with forceps.There was no patient injury.
Additional Manufacturer Narrative
Additional information: b5, 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 one damaged yellow part and one shipping wedge were received.The reload was fully fired and the interlock was engaged.The jaw of the reload was open.Damage was found on the shipping wedge.Functional testing found 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 shipping wedge broke.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if the shipping wedge pull tab is pulled in a lateral fashion towards the distal end of the sulu channel rather than away from the channel, or if the loading unit is clamped prior to removal of the yellow shipping wedge.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: instructions for proper loading or reload.Clearly states instructions for proper use of stapler.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: 21728433
• Report Number: 1219930-2025-01490
• Device Sequence Number: 17075858
• Product Code: GDW
• UDI-Device Identifier: 10884521543737
• UDI-Public: 10884521543737
• 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): 06/03/2025

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: SIG30CTAV
• Device Catalogue Number: SIG30CTAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 03/30/2025
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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