MAUDE Adverse Event Report: COVIDIEN EEA; STAPLE, IMPLANTABLE

Model Number	EEAXL25
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
25mm eea circular stapler being used in patient.Surgeon fired stapler as directed and when it was being pulled out, the anvil detached from the stapler and remained inside the patient.Anvil was successfully and safely retrieved.

• Brand Name: EEA
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 24144421
• Report Number: 24144421
• Device Sequence Number: 15824362
• Product Code: GDW
• UDI-Device Identifier: 10884523006056
• UDI-Public: (01)10884523006056
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 12/30/2025
• Report Date (Section F): 12/30/2025

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: EEAXL25
• Device Catalogue Number: EEAXL25
• Device Lot Number: P5K1069
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2026
• 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
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Date Report Sent to FDA: 12/30/2025