MAUDE Adverse Event Report: COVIDIEN LP EEA; STAPLER, SURGICAL

Model Number	TRIEEA25MT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a surgical procedure to reverse a colostomy, two circular staplers did not function properly.The anvil portion appeared to be bent so the equipment could not engage and staple properly.The surgeons made several attempts to fit the pieces together as designed however they determined that the bent metal piece was not fixable and they eventually got a different size which worked appropriately.

• Brand Name: EEA
• Common Device Name: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 24953127
• Report Number: 24953127
• Device Sequence Number: 15979012
• Product Code: GAG
• UDI-Device Identifier: 10884521593008
• UDI-Public: (01)10884521593008(17)300131(10)P5B0832
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/03/2026
• Report Date (Section F): 04/03/2026

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: P5B0832
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Female
• Date Report Sent to FDA: 04/03/2026