MAUDE Adverse Event Report: Covidien Endo GIA Ultra; STAPLE, IMPLANTABLE

Model Number	EGIAUXL
Medical Device Problem Codes	Component or Accessory Incompatibility (2897); Mechanical Jam (2983); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a procedure, prior to patient use, the device jammed and the reload was locked and unable to be loaded.A new product was used to resolve the issue.There was no patient injury.
Event or Problem Description
According to the reporter, during a procedure, prior to patient use, the reload got stuck and unable to be loaded.A new reload was used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
Concomitant product: egia45avm egia45avm egia 45 artic vasc med sulu (lot #p5j1162).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: b3, d1, d4, d8, g3, g4, h4, h6 further review of this event found the device is not considered a potential contributory cause.This event has been reassessed as no n-reportable and no further reports will be submitted.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 Ultra
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Covidien; sabanetas industrial park; ponce PR 00716 -440
• Manufacturer (Section G): Covidien; sabanetas industrial park; ponce PR 00716 -440
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(800)646-4633
• MDR Report Key: 50766577
• Report Number: 2647580-2026-02680
• Device Sequence Number: 21138320
• Product Code: GDW
• UDI-Device Identifier: 10884523003550
• UDI-Public: (01)10884523003550(17)300731(10)P5H0932(20)02
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2026

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: EGIAUXL
• Device Catalogue Number: EGIAUXL
• Device Lot Number: P5H0932
• 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: 08/20/2026
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/15/2026
• Supplement Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 08/14/2025
• 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 H11.
• Patient Age: 37 YR
• Patient Sex: Female