MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	TRIEEA31MT
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Laceration(s) (1946); Tissue Breakdown (2681)
Date of Event	10/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant product: trieea31mt, cir stplr trieea31mt medthk wt (lot#: p5d1132).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 the rectum resection, the anvil became stuck to the surrounding tissue.It was also noted that the anvil did not tilt after firing.The surgeon stapled again with a different circular stapler from a different lot and the anvil got stuck again, at which point the surgeon made a temporary colostomy bag as an intervention.Additional resection and re-stapling was performed to resolve the issue.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.H3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the proximal head was stuck and did not disconnect from the colical stump and the anvil did not tilt after firing.The reported issues could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.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.
Event or Problem Description
Pli 10 and pli 20 - it was reported that during the rectum resection, in both anastomosis attempts with two circular stapler, the proximal head was stuck and did not disconnect from the colical stump, creating a continuous opening on the anastomosis which required resection and re-sewing of the anastomosis on the first attempt and, on the second attempt, for a larger longitudinal continuous opening of the rectum.It was also noted that the anvil did not tilt after firing.It was necessary to proceed with a further resection with sinking of the rectal stump and simultaneous creation of a temporary colostomy.No further attempts were made to construct the anastomosis in order to prevent future potential rectal tissue recanalization.
Additional Manufacturer Narrative
Additional information: b5, g3, h6 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: 23492954
• Report Number: 2647580-2025-03319
• Device Sequence Number: 9106876
• Product Code: GAG
• UDI-Device Identifier: 10884521593046
• UDI-Public: (01)10884521593046(17)300331(10)P5D1015
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2026

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: TRIEEA31MT
• Device Catalogue Number: TRIEEA31MT
• Device Lot Number: P5D1015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Supplement Date Received by Manufacturer: 11/11/2025; 12/30/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 11/19/2025; 01/15/2026
• Date Device Manufactured: 04/09/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown