MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	EEA31
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during a procedure, the device had a faulty connection between the anvil and the housing, so when closing the anvil, it slipped and could not be operated on.Another circular stapler was opened to solve the issue.Surgical time was extended by 30 minutes due to product replacement.There was no patient injury.
Additional Manufacturer Narrative
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: b5, d3 (mfr name and address), d4 (udi#), d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Functional testing found that the green bar was visible within the indicator window when the twist knob was fully closed.The instrument was applied to the appropriate test media producing acceptable results.It was reported that the device had a faulty connection between the anvil and the housing.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the anvil is manipulated with excessive force during the attachment to the instrument, or if the anvil is mishandled during the removal of fitting accessories.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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 low anterior resection, the device had a faulty connection between the anvil and the housing, so when closing the anvil, it slipped and could not be operated on.Another circular stapler was opened to solve the issue.Surgical time was extended by 30 minutes due to product replacement.There was no patient injury.

• 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: 22357515
• Report Number: 2647580-2025-01988
• Device Sequence Number: 8081898
• Product Code: GAG
• UDI-Device Identifier: 10884523005554
• UDI-Public: (01)10884523005554(17)290228(10)P4C0994
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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: EEA31
• Device Catalogue Number: EEA31
• Device Lot Number: P4C0994
• 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: 06/08/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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
• Patient Sex: Unknown