MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	EEAXL21
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an esophageal collis using a circular stapler in the abdomen, the small green cartridge ring fell out of the end of the stapler, rendering the instrument unusable with pieces falling into the patient cavity.All pieces were retrieved by the surgeon without the need for x-ray imaging.The device was replaced, and a different device was used to complete the procedure.The surgical time was extended due to the product issue.
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
H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the anvil of the instrument was tilted and separated from the instrument.Further inspection of the anvil cutting ring showed deep traces of knife impression and the ring was received completely severed.It was reported that the small green cartridge ring fell out of the end of the stapler, rendering the instrument unusable with pieces falling into the patient cavity.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: do not use the stapler with 3.5-millimter (mm) staples on any tissue that will not comfortably compress to 1.5mm in thickness.The instrument should not be used if unusual effort is required to turn the twist knob in order to visualize at least a portion of the green bar in the indicator window.Do not use the stapler if unusual effort is required to turn the twist knob in order to visualize at least a portion of the green bar in the indicator window.After attaching the anvil to the instrument, verify that the orange band on the instrument integrated trocar has been completely covered by the anvil/center rod prior to approximating the anvil to ensure proper assembly of the anvil to the instrument.Applying gentle counter traction on the distal bowel during approximation may minimize excessive tissue incorporated into the barrel of the stapler.Make certain the space between the cartridge and anvil is closed and ensure that the green bar is visible in the indicator window prior to firing the stapler.The safety will not release if the green bar is not visible in the indicator window.Ensure that the tissue thickness can comfortably compress to 2mm for staplers with 4.8mm staples and 1.5mm for staplers with 3.5mm staples.Excess tissue thickness may result in unacceptable staple formation and/or incomplete knife cut.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: 22678222
• Report Number: 2647580-2025-02415
• Device Sequence Number: 8937069
• Product Code: GAG
• UDI-Device Identifier: 10884523005578
• UDI-Public: (01)10884523005578(17)280531(10)P3F0105
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/18/2025

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: EEAXL21
• Device Catalogue Number: EEAXL21
• Device Lot Number: P3F0105
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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