MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	EEAXL28
Medical Device Problem Codes	Failure to Form Staple (2579); Failure to Cut (2587); Firing Problem (4011)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a laparoscopic adjustable gastric banding procedure, the stapler handle did not fully close and there was significant resistance during firing, resulting in an incomplete staple line with staples that were partially fired and not cut.Most of the staples were removed with the stapler, but approximately four staples remained embedded and only partially closed in the rectal stump, necessitating their removal.The anvil was then removed and replaced with a new one, and the bottom of the stapler was reinserted, allowing the post to be brought through the existing hole from the first attempt.The procedure was extended by one hour due to firing issues with the stapler.The issue was resolved by resecting and re-stapling.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: "medtronic conducted an investigation based upon all information received.The involved device was not returned.A visual inspection of the staple guide found the instrument to be partially applied, with approximately half of the staples remaining partially formed within the staple guide.Further inspection showed the green bar was not visible in the indicator window and the safety feature was engaged; the staple guide was securely attached to the instrument with no observed damage.After actuating the handle, the pusher fingers appeared intact, and microscopic examination revealed divots on the knife blade.It was reported that the staple line incomplete, difficult to fire and partially cut.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the instrument handle compression is not completed or if the instrument is applied against an excessive amount of tissue during the clinical application.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: when firing the stapler, make sure to fully squeeze the instrument handle until the metal underside of the handle contacts the stapler body to the fullest extent.Partial or incomplete handle squeezes 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: 24070370
• Report Number: 2647580-2026-00112
• Device Sequence Number: 13106579
• Product Code: GAG
• UDI-Device Identifier: 10884523006131
• UDI-Public: (01)10884523006131(17)300228(10)P5C1289
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K221003
• 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): 04/02/2026

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 Model Number: EEAXL28
• Device Catalogue Number: EEAXL28
• Device Lot Number: P5C1289
• 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: 01/07/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• 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