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

Model Number	EGIA45AVM
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: egiaustnd egiaustnd endogia ultra univ std stap - (lot#p5l1128); egiaustnd egiaustnd endogia ultra univ std stap - (lot#p5l1130); egiaushort egiaushort endogia ultra univ sht stap - (lot#p5l1199); unknown egia su unknown endo gia sulu - (lot#unknown); unknown egia su unknown endo gia 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
It was reported that during an open left nephrectomy, while attempting to staple vascular tissue, the three manual staplers did not fire despite the surgeon being able to press the green safety button and squeeze the handle.The procedure was extended by approximately 45 minutes due to these firing issues.Suturing was performed as a staple line replacement to address the situation.
Additional Manufacturer Narrative
Additional information: d1, d3 (street1, mfr city, mfr region, postal code), d4 (model#, catalog#, expiration date, lot#, unique identifier (udi)#), d8, d10, g3, g4 (pma / 510(k)#), h4 d10 concomitant products: egiaustnd egiaustnd endogia ultra univ std stap - (lot#p5l1128); egiaustnd egiaustnd endogia ultra univ std stap - (lot#p5l1130); egiaushort egiaushort endogia ultra univ sht stap - (lot#p5l1199); egia45avm, egia45avm egia 45 artic vasc med sulu - (lot#p5j0901); egia45avm, egia45avm egia 45 artic vasc med sulu - (lot#p5j0901) 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; sabanetas industrial park; ponce,pr CT 00716 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce,pr CT 00716 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24664462
• Report Number: 1219930-2026-01855
• Device Sequence Number: 9289590
• Product Code: GDW
• UDI-Device Identifier: 10884523003178
• UDI-Public: (01)10884523003178(17)300831(10)P5J0901(20)07
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: EGIA45AVM
• Device Catalogue Number: EGIA45AVM
• Device Lot Number: P5J0901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 09/02/2025
• 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 NOTE ON H11.
• Patient Sex: Unknown