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

Model Number	EGIARADMT
Medical Device Problem Codes	Failure to Fire (2610); Mechanics Altered (2984)
Health Effect - Clinical Codes	Tissue Breakdown (2681); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
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
According to the reporter, after firing to resect a small lung tissue for a frozen tissue test, there was no staple line formation.Another reload was used to complete the case.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 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, intra-operatively, after firing to resect a small lung tissue for a frozen tissue test, the firing completed tone was heard but the tissue was not cut and the staples were not deployed.The device did not fire.Another reload was used to complete the case.There was no patient injury.
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.Visual inspection noted that the jaws in an open position, with staple pushers visible along one-third of the cartridge from the proximal end and staple strike marks present in the anvil pockets, indicating firing.The device was assembled and applied, the reload was placed into a representative instrument, the interlock was overridden, and the unit was fired on test media.All remaining staples deployed properly, the media was cleanly transected, and the reload interlock was confirmed to function as intended.It was reported that the tissue was not cut and the staples were not deployed.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 of the device partially fired that is related to the reported condition.The product analysis noted evidence that the device was not used as intended.This issue can 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: 23796796
• Report Number: 1219930-2025-05761
• Device Sequence Number: 21451814
• Product Code: GDW
• UDI-Device Identifier: 10884521057784
• UDI-Public: (01)10884521057784(17)280731(10)N3G1882Y
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

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: EGIARADMT
• Device Catalogue Number: EGIARADMT
• Device Lot Number: N3G1882Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 02/06/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 12/22/2025; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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
• Patient Sex: Unknown