MAUDE Adverse Event Report: COVIDIEN SURGICAL EEA ORVIL; STAPLE, IMPLANTABLE

Model Number	EEAORVIL25A
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Form Staple (2579); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: b1, b2, b5, g3, h1 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 laparoscopic distal esophagectomy, the staple line was incomplete.The procedure was converted from la paroscopic to open to retrieve the anvil.Suturing was performed as a staple line replacement and anastomosis.
Additional Manufacturer Narrative
D10.Concomitant products: eeaxl2535, eeaxl2535 eea xl 25mm-3.5 sgl use stap (lot#: p5h1160).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 distal esophagectomy, the staple line was incomplete.A thoracotomy was performed to retrieve the anvil.Suturing was performed as a staple line replacement and anastomosis.

• Brand Name: EEA ORVIL
• 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: 25453373
• Report Number: 1219930-2026-03681
• Device Sequence Number: 10409797
• Product Code: GDW
• UDI-Device Identifier: 10884521042872
• UDI-Public: (01)10884521042872(17)270831(10)N4J1568Y
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 06/15/2026

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: EEAORVIL25A
• Device Catalogue Number: EEAORVIL25A
• Device Lot Number: N4J1568Y
• 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: 05/14/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 06/15/2026
• Date Device Manufactured: 09/10/2024
• 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