MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	EEAXL2535
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Laceration(s) (1946)
Date of Event	03/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during esophagogastric anastomosis, the oral anvil was attached to the stapler; however, the anvil did not change from the tilted position to the normal (upright) position at the time of anastomosis.Despite attaching and detaching it several times, the anvil position did not change during firing.The anvil head of the oral anvil did not return to the upright position.As a result, the procedure was converted to a laparotomy, extending the surgical time by more than 60 minutes.A new stapler was used to resolve the issue.
Additional Manufacturer Narrative
D10 concomitant product: eeaorvil25a, eeaorvil25a eea orvil 25mm automaticdv, (lot #n4k2133y) 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: EEA
• Common Device Name: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): COVIDIEN; sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: mike bocchino ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 8006464633
• MDR Report Key: 24645381
• Report Number: 2647580-2026-00761
• Device Sequence Number: 13208016
• Product Code: GAG
• UDI-Device Identifier: 10884523006124
• UDI-Public: (01)10884523006124(17)290831(10)P4J0837(20)03
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K221003
• 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
• Report Date (Section B): 06/29/2026

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: EEAXL2535
• Device Catalogue Number: EEAXL2535
• Device Lot Number: P4J0837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 06/26/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown