MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	TRIEEA31XT
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949); Mechanics Altered (2984)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	05/05/2025
Type of Reportable Event	Serious 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.
Event or Problem Description
According to the reporter, in a lower anterior resection, the surgeon turned the knob of the circular stapler when approximating the colon for the anastomosis of the proximal and distal colon.The green in the window was seen, but the safety lock would not come off.The device was then forcedly fired, and a piece of the safety broke off when firing.The staples were only deployed posteriorly and not anteriorly, resulting in an incomplete staple line.The tissue was resected and re-stapled with a second circular stapler from the same lot and the firing went smoothly.However, the donuts were not optimal as the surgeon had to go much lower with the second firing.The bubble leak test was negative, but the patient was required an additional surgery.
Additional Manufacturer Narrative
Additional information: d3 (mfr name and street 1), d4 (udi), 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 staple guide noted that the instrument was fully applied.The green bar was not visible in the indicator window and the safety feature was broken.The handle housing was cracked.The staple guide was observed to be attached to the instrument with no damage to the staple guide.The handle was damaged and could not be fully actuated.After actuating the handle, the pusher fingers appeared to be intact and inspection under the microscope displayed no damage to the knife blade.The anvil of the instrument was observed to be tilted and attached to the instrument.The anvil cutting ring showed no traces of knife impression and the ring was received intact.It was reported that the staples did not deploy, there was difficulty with safety and there was a component that disengaged.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.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 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.Make certain that 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; and 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.Failure to squeeze the instrument handle fully during firing may result in unacceptable staple formation or an incomplete knife cut.This may result in leakage.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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22106541
• Report Number: 2647580-2025-01665
• Device Sequence Number: 7122274
• Product Code: GAG
• UDI-Device Identifier: 10884521593053
• UDI-Public: (01)10884521593053(17)290731(10)P4H1028(20)03
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K221005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: TRIEEA31XT
• Device Catalogue Number: TRIEEA31XT
• Device Lot Number: P4H1028
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown