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

Model Number	SIG30CTAV
Medical Device Problem Codes	Break (1069); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a video-assisted thoracoscopic surgery (vats) esophagectomy, after the firing was completed and after the jaws were opened to release to release the tissue, the articulation did not return to its original position, and it was difficult to return the articulation to its original position, that caused damage to the lock ring.It was also reported that the reload was difficult to unload.The articulation was forcibly corrected and the trocar was removed along with the stapler.There was no patient injury.
Additional Manufacturer Narrative
D10 concomitant products: sigadaptstnd, sig power sigadaptstnd linear adapter (serial#(b)(6)); sigphandle, sig power sigphandle handle (serial#unknown); sigpshell, sig power sigpshell control shell (serial#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.
Additional Manufacturer Narrative
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the reload was received attached to the returned adapter.The reload was fully fired.The jaw of the reload was open.The adapter was broken.Functional testing found that the reload came without packaging.The reload was partially inserted into the adapter, but was misaligned.The reload could not be removed from the adapter by pressing the blue unload switch back then twisting and removing the reload from the adapter.The adapter was partially taken apart to allow the reload to be removed.The reload was broken in order to be removed.The reload was fully fired.Due to the noted damage, functional testing was precluded.It was reported that the device was difficult to removed and instrument broken.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur if the reload is over torqued during unloading and / or if an attempt is made to unload the reload without using the release button.It was also reported that the device was difficult to straighten.The reported issue could not be 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.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: 20461866
• Report Number: 1219930-2024-04887
• Device Sequence Number: 20781968
• 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): 01/10/2025

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: 10/07/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/10/2025
• 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