MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC CIRCULAR MECH XL SEAL 25MM; STAPLE, IMPLANTABLE

Model Number	ECS25B
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Stapler was being used for surgical procedure and was not functioning properly.Stapler would not fire and deploy a staple.The device was not able to complete its intended task.Stapler was removed from the field and a new stapler was used successfully.The malfunctioning stapler was pulled as a peel pack (ref #ecs25b, lot #c9en6f).

• Brand Name: CIRCULAR MECH XL SEAL 25MM
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 21066660
• Report Number: 21066660
• Device Sequence Number: 3390676
• Product Code: GDW
• UDI-Device Identifier: 10705036022923
• UDI-Public: (01)10705036022923(17)290731(10)C9EN6R
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/11/2024
• Report Date (Section F): 12/11/2024

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: ECS25B
• Device Catalogue Number: ECS25B
• Device Lot Number: C9EN6R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2025
• 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
• Patient Sex: Male
• Date Report Sent to FDA: 12/11/2024