MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	EEA2135
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during an open esophagectomy, the safety lever broke.Another circular stapler was used to resolve the issue.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: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection of the instrument noted the safety stops were broken.The staple guide noted the presence of a full complement of staples.Further inspection noted that the green bar was visible in the indicator window and the safety feature was not engaged.The staple guide was observed to be attached to the instrument with no damage.The pusher fingers appeared to be intact and inspection under the microscope displayed no damage to the knife blade.The anvil was observed to be not tilted and attached to the instrument.Further inspection of the anvil cutting ring showed no traces of knife impression and the ring was received intact.Functional testing found that the wing nut and safety functioned properly upon rotating the twist knob.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.Pusher-fing ers and knife advanced when the handle was squeezed and the knife cut the media cleanly and completely and a full complement of staples was deployed and properly formed.The device also produced all audible, tactile and visual indicators during the functional testing.It was reported that the safety lever broke.The reported issue was confirmed.The most likely cause was determined to be manufacturing related.Internal process improvements have been initiated to mitigate this issue.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.

• 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: 24938499
• Report Number: 2647580-2026-01117
• Device Sequence Number: 16115303
• Product Code: GAG
• UDI-Device Identifier: 10884523004724
• UDI-Public: (01)10884523004724(17)260630(10)P1G0587
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

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 Expiration Date: 06/30/2026
• Device Model Number: EEA2135
• Device Catalogue Number: EEA2135
• Device Lot Number: P1G0587
• 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: 04/12/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 07/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2021
• 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