MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	TRIEEA25MT
Medical Device Problem Codes	Material Twisted/Bent (2981); Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
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 rectal resection, while on rectal anastomosis, the attachment of the anvil was difficult and the shaft of the anvil was bent.A new product of the same product number was taken out and used to resolve the issue.There was no patient injury.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the staple guide noted the presence of a full complement of staples.Further inspection noted that the green bar was visible in the indicator window and the safety feature was not engaged.The staple guide was observed to be attached to the instrument with no damage to the staple guide.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 not tilted and separated from the instrument.Further inspection of the anvil cutting ring showed no traces of knife impression and the ring was received intact.One of the retainer legs of the anvil was observed to be bent.It was reported that the attachment of the anvil was difficult and the shaft of the anvil was bent.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur if the anvil is manipulated with excessive force during the attachment to the instrument, or if the anvil is mishandled during the removal of fitting accessories.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: fully extend the center shaft of the stapler by turning the twist knob counterclockwise until it stops.Mate the anvil/center rod assembly to the stapler by inserting the blunt center rod into the center shaft of the stapler and push firmly until the center rod clicks into its fully seated position.This click will be tactile and audible.Manually inspect the attachment to ensure that the center rod and stapler are fully mated.Do not grasp/clamp on the legs (open end) of the anvil/center rod assembly.Doing so could bend the legs and make it difficult to attach/detach the anvil to the integrated trocar of the stapler.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: 23930115
• Report Number: 2647580-2025-03946
• Device Sequence Number: 13015202
• Product Code: GAG
• UDI-Device Identifier: 10884521593008
• UDI-Public: (01)10884521593008(17)300430(10)P5E1157(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: TRIEEA25MT
• Device Catalogue Number: TRIEEA25MT
• Device Lot Number: P5E1157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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