MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ECHELON; Stapler, surgical

Model Number	ECH60L
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During a lap-appy "[laparoscopic appendectomy]", stapled appy.Went to remove stapler from articulated position and patient could not.Hat to remove port and then stapler.

• Brand Name: ECHELON
• Common Device Name: Stapler, surgical
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 50753660
• Report Number: 50753660
• Device Sequence Number: 18558990
• Product Code: GAG
• UDI-Device Identifier: 10705036034988
• UDI-Public: (01)10705036034988(17)280229(10)A97P9K
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 07/17/2026
• Report Date (Section F): 07/17/2026

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
• Device Model Number: ECH60L
• Device Catalogue Number: ECH60L
• Device Lot Number: A97P9K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2026
• 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 Sex: Unknown
• Date Report Sent to FDA: 07/17/2026