MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ILS 33MM, CURVED; STAPLE, IMPLANTABLE

Model Number	CDH33A
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The anvil and spike pushed through the proximal transection site posterior to the staple line.After several attempts the anvil spike would not disengage from the anvil utilizing various techniques.A new stapler was obtained and placed.The anvil placed without the spike using a purse string to close around the enterotomy.The endoscopic endonasal approach (eea) was placed via the rectum and the distal spike deployed.The two ends were connected, the stapler closed, and the stapler fired.Inspection of the anastomotic donuts showed an intact distal donut, but the proximal donut was not intact.Leak test was positive, and the defect found anteriorly.

• Brand Name: ILS 33MM, CURVED
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 21228908
• Report Number: 21228908
• Device Sequence Number: 8325549
• Product Code: GDW
• UDI-Device Identifier: 10705036003472
• UDI-Public: (01)10705036003472(17)251031(10)U40R34
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2025
• Report Date (Section F): 01/09/2025

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: CDH33A
• Device Catalogue Number: CDH33A
• Device Lot Number: U40R34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2025
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Date Report Sent to FDA: 01/09/2025