MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON 3000 45MM LONG; STAPLE, IMPLANTABLE

Catalog Number	ECH45L
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, it was observed that the stapler failed with some guard attached.It closed but did not deploy staples and would not reopen.There was no patient consequence nor surgical delay reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/02/2025.D4: batch # unk.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: was the device locked on tissue with the jaws closed? if yes, how was the device removed? what troubleshooting steps were attempted to open the device (e.G.Squeezing the closing trigger while simultaneously depressing the anvil release button, knife reverse switch, manual override)? did the jaws eventually open? attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device lot/batch number, a97v6d, and no non-conformances were identified.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/11/2025.D4: batch #a97r3j.Corrected data: h4 investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that one ech45l device was returned with no apparent damage and with no reload present.During the functional test, a sound of a motor was heard, and the knife didn't move forward to the lockout position.The manual override door was removed and the cam was noted engaged, disconnecting the motor from the drive bar, but the bailout lever is down.The cam was reset and then, it was tested for functionality in the straight position with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples met the staple release criteria.The damage to the device is potentially related to a manufacturing process.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue will be addressed through ethicon endo surgery¿s quality system.The device event log was reviewed.The log indicates that no suspect power cycles were noted.A manufacturing record evaluation was performed for the finished device batch number a97r3j, and no non-conformances were identified.

• Brand Name: ECHELON 3000 45MM LONG
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; 3035526892
• MDR Report Key: 23693328
• Report Number: 3005075853-2025-09102
• Device Sequence Number: 15755885
• Product Code: GDW
• UDI-Device Identifier: 10705036034964
• UDI-Public: (01)10705036034964(10)A97V6D(17)280331
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213633
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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 Catalogue Number: ECH45L
• Device Lot Number: A97V6D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown