MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC ECHELON ENDOPATH; STAPLE, IMPLANTABLE

Model Number	GST45B
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Initial 45 stapler used did not fully fire during the procedure.Stapler was removed and surgeon reviewed the stapler to find if error occurred with usage.A second stapler was opened and loaded with a new blue load; however it also failed to fire completely.A third stapler was then opened with a different lot number thinking it was a batch of staplers malfunctioning.The third stapler was then tried with a white staple load and fired completely.All three staplers and blue loads were wasted on patients chart.Blue loads: gst45b lot:816d72 exp:10-31-28, lot:931c65 exp:07-31-27.

• Brand Name: ECHELON ENDOPATH
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 50378914
• Report Number: 50378914
• Device Sequence Number: 18755639
• Product Code: GDW
• UDI-Device Identifier: 10705036014881
• UDI-Public: (01)10705036014881
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• 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): 08/20/2026
• Report Date (Section F): 08/20/2026

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: Health Professional
• Device Model Number: GST45B
• Device Catalogue Number: GST45B
• Device Lot Number: 931C65
• 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: 08/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2026
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/20/2026