MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	TRIEEA31XT
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	05/16/2025
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
It was reported that during an anterior rectal resection, the circular stapler did not trigger or staple, it only cut the tissues, resulting in the intestine remaining open.
Additional Manufacturer Narrative
Additional information: b1, b2, b5, d4 (udi #), g3, h1, h6 new information has been received pertaining to the event.This event has been reassessed and the reportability has been determined to be a serious injury.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 an anterior rectal resection, the circular stapler did not trigger or staple, it only cut the tissues, resulting in the intestine remaining open.To resolve the issue, the rectal stump was sutured over and a terminal descending stoma was created.It was noted that the procedure was extended by more than 30 minutes.
Additional Manufacturer Narrative
Additional information: d3, g3, g4, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Evaluation noted that the anvil of the instrument was observed to be tilted and separated from the instrument it was reported that staples did not deploy.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the staples all around the circumference of the cut ring.Visual inspection noted that there were staples all around the circumference of the cut ring.The product analysis noted evidence that the device was not used as intended.This issue may result in potential advancement of the handle, which in turn can advance the staples.Partially advanced staples protruding from the cartridge during an attempted insertion through either the abdominal wall or the rectum may cause problems with the insertion and also may cause unacceptable staple formation after firing.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: do not use the stapler with extra thick staple size (black) on any tissue that will not comfortably compress to 3.0 mm in thickness.The instrument should not be used if unusual effort was required to turn the twist knob in order to visualize at least a portion of the green bar in the indicator window and step seven.Do not use the stapler if unusual effort was required to turn the twist knob in order to visualize at least a portion of the green bar in the indicator window.Also, notes: the safety will not release if the green bar was not visible in the indicator window.Caution: the instrument should not be used if unusual effort was required to turn the twist knob in order to visualize at least a portion of the green bar in the indicator window, and caution: do not touch the black twist knob when removing the stapler from the package.Inadvertent turning of the black twist knob may result in the green bar showing in the indicator window and the safety being released.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: 22318981
• Report Number: 2647580-2025-01935
• Device Sequence Number: 8819003
• Product Code: GAG
• UDI-Device Identifier: 10884521593053
• UDI-Public: (01)10884521593053(17)291031(10)P4L0667(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2026

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: P4L0667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 01/09/2026
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 06/30/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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: Female