MAUDE Adverse Event Report: COVIDIEN EEA; STAPLER, SURGICAL

Model Number	TRIEEAXL28MT
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	09/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D10 concomitant products: 176657, 176657 endoclip ii ml 10 appli, (lot number: unknown) 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 left colon resection with enhanced recovery after surgery (eras) and rectopexy, there were firing issues with the circular stapler while reconnecting the rectum with the left colon after resection.The stapler was closed and the green bar indicated the tissue was compressed to firing range, but when fired, no staples were visibly deployed in the tissue or abdomen.The knife blade cut the rectal and colon tissue without deploying staples, resulting in holes in the bowel stumps.The procedure was extended by 30 minutes.To address the defects, suturing was performed to close the holes, another anvil was sewn in for subsequent stapling, and the tissue was resected and re-stapled.The device was replaced with another of the same model, and an anastomosis was successfully created with the replacement stapler.
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.Visual inspection noted that the staple guide noted the instrument was fully applied.Further inspection noted that the green bar was visible in the indicator window and the safety feature was broken.The staple guide was observed to be attached to the instrument with no damage to the staple guide.After actuating the handle, the pusher fingers appeared to be intact and inspection under the microscope displayed divots on the knife blade.The wing nut functioned properly but the safety was broken off.The green bar was visible within the indicator window when the twist knob was fully closed.Pusher-fingers and knife advance when the handle was squeezed.The staple guide popped off.The instrument body label was removed for evaluation of the eccentric washer assembly.Evaluation of the eccentric washer noted that it was secured.It was reported that when fired, no staples were visibly deployed in the tissue or abdomen.The knife blade cut the rectal and colon tissue without deploying staples, resulting in defects (holes) in the bowel stumps.The reported issue was not used as intended.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: ¿make certain 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 (partial firing) may result in unacceptable staple formation and/or an 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: 23349204
• Report Number: 2647580-2025-03165
• Device Sequence Number: 20776063
• Product Code: GAG
• UDI-Device Identifier: 10884521593121
• UDI-Public: (01)10884521593121(17)300228(10)P5C1124(20)03
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: TRIEEAXL28MT
• Device Catalogue Number: TRIEEAXL28MT
• Device Lot Number: P5C1124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown