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

Model Number	EGIA30CTAVM
Medical Device Problem Codes	Entrapment of Device (1212); Retraction Problem (1536)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: egiaustnd, egiaustnd endogia ultra univ std stap, (lot number: p5c1368s) 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, during a laparoscopic thoracic lobectomy, while detaching the pulmonary lobar artery, the reload fired normally, but the black retraction knob on the handle would not pull despite numerous attempts.The vessel being detached at the time was a pulmonary artery.Once bleeding occurred, thoracotomy was necessary and there was at least 2000 milliliters (ml) of blood loss.Furthermore, there was very little tissue surrounding the vessel, leaving no room for further freeing and detachment.After a long period of effort, using surgical forceps to remove the tissue close to the clamp little by little and mobilizing the surrounding tissue, the already closed vessel was finally separated from the reload slowly without bleeding at the proximal end.The procedure was extended for 30 minutes or more due to the issue.
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 noted that the reload was returned still attached to the handle and locked on tissue.The reload had been fully fired.The laminate hooks were examined under the microscope and damage to one side was noted.During functional testing, the reload was loaded into a representative instrument.The interlock was not engaged.The reload was cycled without hesitation or binding and was applied to test media.The reload interlock did not engage.It was reported that there was difficulty to retract the knife blade and the instrument locked on tissue.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue can occur when there is application over tissue that is beyond the recommended thickness range and application with an obstacle incorporated in the jaws.In any of these circumstances, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract.In addition, staples may not form properly and tissue may not be fully transected.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtro nic quality specifications.The instructions included with this device provide the following guidance: always inspect the tissue thickness and select an appropriate staple size prior to application of the endo gia¿ ultra universal short, endo gia¿ ultra universal or endo gia¿ ultra universal xl stapler.Overly thick or thin tissue may result in unacceptable staple formation.When positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.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: 23344114
• Report Number: 1219930-2025-04797
• Device Sequence Number: 18509233
• Product Code: GDW
• UDI-Device Identifier: 10884523003147
• UDI-Public: (01)10884523003147(17)300131(10)N5B1546Y(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
• 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
• Report Date (Section B): 12/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: EGIA30CTAVM
• Device Catalogue Number: EGIA30CTAVM
• Device Lot Number: N5B1546Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown