MAUDE Adverse Event Report: COVIDIEN SURGICAL ENDO GIA; STAPLE, IMPLANTABLE

Model Number	EGIA45AXT
Medical Device Problem Codes	Failure to Read Input Signal (1581); Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that during a procedure, the reload was not recognized.The device was replaced with a new reload.No patient complications have been reported as a result of this event.Medtronic's initial evaluation of the incident is that the reload was partially fired with the interlock engaged.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the reload was loaded into a representative power handle, clamshell, and adapter.The reload communication with the handle was verified, and the reload was recognized.The reload was removed.The reload was loaded into a representative instrument (0802).The reload interlock was tested and found to function properly.The interlock was overridden and the reload was applied to test media all remaining staples were placed and test media was cleanly transected.The interlock was tested and found to function properly.It was reported that the reload was not recognized.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: partial firing.Visual inspection noted that the reload was partially fired with the interlock engaged.The jaws were open.Staple pushers were visible at the 2 cm cut line.The product analysis noted evidence that the device was not used as intended.This issue may occur if the user presses the open key prior to the i-beam reaching the end of the reload.Following retraction, the safety interlock feature will engage and prevent the reload from firing a second time.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: failure to completely fire the reload will result in an incomplete cut and/or incomplete staple formation, which may result in poor hemostasis and/or leakage.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 SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN SURGICAL; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24055708
• Report Number: 1219930-2026-00208
• Device Sequence Number: 15916553
• Product Code: GDW
• UDI-Device Identifier: 10884523003185
• UDI-Public: (01)10884523003185(17)271231(10)N3A0094Y
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: EGIA45AXT
• Device Catalogue Number: EGIA45AXT
• Device Lot Number: N3A0094Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2023
• 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
• Patient Sex: Unknown