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

Model Number	EGIA45AMT
Medical Device Problem Codes	Entrapment of Device (1212); Retraction Problem (1536); Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: egiaushort, egiaushort endogia ultra univ sht stap, (lot # unknown); egia45amt, egia45amt egia 45 artic med thick sulu, (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, in a thoracoscopic right upper lobectomy, when in the lung parenchyma, the device was stiff to squeeze.There was no issue with the staple line but there was failure to retract knife blade after firing.The jaws could not be removed from the tissue.The reload had tissue and a staple remaining at the root of the jaws.The return knob was pulled back forcefully with both hands to remove the device from the tissue.The surgical team struggled to pull back the device for 15 minutes.There was no patient injury.

• 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: 21149455
• Report Number: 1219930-2025-00258
• Device Sequence Number: 21111581
• Product Code: GDW
• UDI-Device Identifier: 10884521820555
• UDI-Public: 10884521820555
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

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: EGIA45AMT
• Device Catalogue Number: EGIA45AMT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/25/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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