MAUDE Adverse Event Report: COVIDIEN LP EEA; STAPLE, IMPLANTABLE

Model Number	TRIEEAXL28MT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon has a scheduled robotic colostomy takedown and during the colon anastomosis part of case, we were using the covidien circular stapler (trieeaxl28mt).After anastomosing the colon, the first assist was instructed to retract and remove the stapler but was having difficulty pulling the whole device out of the colon.The staff could see on the video monitor as well that there is some resistance.Surgeon switch position with the first assist to remove the circular stapler himself and was able to do so, but the anvil part of the device was lodged inside the colon.We utilized the gi cart and scope to try to remove the anvil.Surgeon was able to remove the anvil out of the colon through the rectum and out of the anus.The anvil contained two complete anastomosis rings which was sent to pathology per surgeon.The covidien circular stapler including the anvil was save and was given to or supervisor.The procedure proceeded without further issues and the patient was brought to pacu after the case was finished.

• Brand Name: EEA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN LP; 60 middletown ave; north haven CT 06473
• MDR Report Key: 21618359
• Report Number: 21618359
• Device Sequence Number: 12895590
• Product Code: GDW
• UDI-Device Identifier: 10884521593121
• UDI-Public: (01)10884521593121
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/12/2025
• Report Date (Section F): 03/12/2025

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: TRIEEAXL28MT
• Device Catalogue Number: TRIEEAXL28MT
• Device Lot Number: P3M0756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Date Report Sent to FDA: 03/12/2025