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

Model Number	EGIA30CTAVM
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	Tissue Breakdown (2681)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant products: egiaustnd, egiaustnd endogia ultra univ std stap, (lot # p1m0706s) egia30ctavm, egia30ctavm egia30 curved vas med sulu, (lot # n4j1923y) egia45ctav, egia45ctav egia 45 curved vascular sulu, (lot # n4c1841y).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 uniportal thoracoscopic lobectomy, the stapler exhibited poor distal staple formation and incomplete distal staple lines for all three reloads.Reinforced suture with thread was required to fix the incomplete staple lines.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.H3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection and functional testing found no notable condition.It was reported that during a uniportal thoracoscopic lobectomy, the stapler exhibited poor distal staple formation and incomplete distal staple lines for all three reloads.The reported issues could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition of lock ring out of position.The product analysis noted evidence that the device was not used as intended.This issue may occur if the lock ring is inadvertently moved out of position during handling of the reload.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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: 22888930
• Report Number: 1219930-2025-03691
• Device Sequence Number: 4849361
• Product Code: GDW
• UDI-Device Identifier: 10884523003147
• UDI-Public: (01)10884523003147(17)290930(10)N4J1923Y(20)02
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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
• Report Date (Section B): 10/29/2025

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: EGIA30CTAVM
• Device Catalogue Number: EGIA30CTAVM
• Device Lot Number: N4J1923Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2024
• 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