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

Model Number	ECH60L
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Stapler fired with inability to immediately open manually.It appears the stapler did have a portion of a robotic instrument tip within the jaw.The resident clamped the tissue prior to firing the stapler and did not feel the obstruction.We were able to get ahold of the rep and eventually open jaw.

• Brand Name: ECHELON
• Common Device Name: Stapler, surgical
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 50753150
• Report Number: 50753150
• Device Sequence Number: 9550918
• Product Code: GAG
• UDI-Device Identifier: 10705036034988
• UDI-Public: (01)10705036034988
• 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): 07/20/2026
• Report Date (Section F): 07/20/2026

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: Other
• Device Model Number: ECH60L
• Device Catalogue Number: ECH60L
• Device Lot Number: A99D5Z
• 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: 07/20/2026