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

Model Number	EGIA45CTAV
Medical Device Problem Codes	Retraction Problem (1536); Misfire (2532); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a procedure, on the second shot, the load did not advance to the end of the stapling and did not retract and got stuck.All possible procedures were done, such as restarting the device, disconnecting the stem, an attempt to replace the shell was also done but it was not successful.To complete the procedure, a manual stapler from a different manufacturer was used.There was no active bleeding due to what happened, but it impacted an increase of three hours in the procedure.It was noted, after manual stapling, the user replaced the rod with a new one, and the procedure continued without complications.
Additional Manufacturer Narrative
D10 concomitant products: sigphandle, sig power sigphandle handle (sn:(b)(6); sigpshell, sig power sigpshell control shell (lot#n4b1876y); sigadaptstnd, sig power sigadaptstnd linear adapter (sn:(b)(6).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
Additional information: information received shows that this event is a duplicate of another issue reported under regulatory report#: 1219930-2025-00066.This file will be closed and all further updates processed under the above-referenced report for this event.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
Duplicate of (b)(4).

• 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: 21107336
• Report Number: 1219930-2025-00161
• Device Sequence Number: 15440736
• Product Code: GDW
• UDI-Device Identifier: 10884523003192
• UDI-Public: 10884523003192
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2025

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/04/2025
• 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