MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN ENDO GIA; STAPLE, IMPLANTABLE

Model Number	EGIA45CTAV
Medical Device Problem Codes	Entrapment of Device (1212); Retraction Problem (1536); Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
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).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 procedure, in the second shot, the load did not advance to the end of the staple, and the knife did not retract as well, locking the jaws of the device to the tissue.All possible solutions have been done, such as restarting the handle, disconnecting the adapter, and using the manual retraction tool.Shell replacement was also attempted, but all of these did not resolve the issue.To complete the case, a manual stapler from another manufacturer was used.It was noted that the procedure was extended for more than three hours.
Additional Manufacturer Narrative
Additional information: b5, g3 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 lobectomy, in the second shot, the load did not advance to the end of the staple, and the knife did not retract as well, locking the jaws of the device to the tissue.All possible solutions have been done, such as restarting the handle, disconnecting the adapter, and using the manual retraction tool.Shell replacement was also attempted, but all of these did not resolve the issue.To complete the case, a manual stapler from another manufacturer was used.It was noted that the procedure was extended for more than three hours and the retraction tool worked with other devices.
Additional Manufacturer Narrative
Additional information: b5, g3 correction: a1.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 lobectomy, in the second shot, the load did not advance to the end of the staple, and the knife did not retract as well, locking the jaws of the device to the tissue.All possible solutions have been done, such as restarting the handle, disconnecting the adapter, and using the manual retraction tool.Shell replacement was also attempted, but all of these did not resolve the issue.To complete the case, a manual stapler from another manufacturer was used.There was no active bleeding due to what happened, but the procedure was extended for more than three hours and the retraction tool worked with other devices.It was noted, after manual stapling, the user replaced the rod with a new one, and the procedure continued without complications.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 correction: d4 (unique identifier (udi) #) h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the reload came attached to a powered adapter.The reload was fully fired and very slightly retracted.The reload was noted to have damage to the blowout plate, laminates, and cover tube.Functionally, 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.It was reported that the device partially fired.The reported issue could not be confirmed.The most likely cause could not be established from the information available.Internal process improvements have been initiated to mitigate this issue.It was also reported that the instrument locked on tissue and the knife was difficult to retract.The reported issues were 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: ENDO GIA
• 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: 21073937
• Report Number: 1219930-2025-00066
• Device Sequence Number: 12872855
• Product Code: GDW
• UDI-Device Identifier: 10884523003192
• UDI-Public: (01)10884523003192(17)280331(10)N3D0003Y
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K111825
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/04/2025

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: EGIA45CTAV
• Device Catalogue Number: EGIA45CTAV
• Device Lot Number: N3D0003Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 12/23/2024; 01/30/2025; 08/01/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/07/2025; 02/04/2025; 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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