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

Model Number	EGIA45AMT
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10.Concomitant product: egiaustnd, egiaustnd endogia ultra univ std stap, (lot # p5l0924).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 an appendectomy, the stapler did not fire.The surgeon was able to press the green button but was unable to squeeze the handle.The clamp only opened and closed.Another device from the same code was used to complete the case.The surgical time was extended as a result.
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, in an appendectomy, the stapler did not fire.The surgeon was able to press the green button but was unable to squeeze the handle.The clamp only opened and closed.Another device from the same code was used to complete the case.The surgical time was extended for two minutes as a result.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d9 (return date), g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the reload was prefired with the interlock engaged.Staples were protruding from the proximal end of the staple cartridge channel.The proximal end of the reload adapter was broken.Evaluation noted that the articulation rod was broken off and the broken section of reload adapter remained in the distal end of the adapter.It was reported that the stapler did not fire.The surgeon was able to press the green button but was unable to squeeze the handle.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur due to over flexure of the reload while attached to the instrument.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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: 24577275
• Report Number: 1219930-2026-01612
• Device Sequence Number: 9232664
• Product Code: GDW
• UDI-Device Identifier: 10884521820555
• UDI-Public: 10884521820555
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup,Followup
• Report Date (Section B): 05/22/2026

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: EGIA45AMT
• Device Catalogue Number: EGIA45AMT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 03/20/2026; 05/12/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 03/25/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 21 YR
• Patient Sex: Female