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

Catalog Number	ECH45C
Medical Device Problem Codes	Difficult to Open or Close (2921); Insufficient Device Problem Information (3190); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/28/2026 d4: batch #571d91 additional information was requested, and the following was obtained: did the device deliver any staples? no if yes, were the staples formed properly? not applicable if yes, was the staple line complete?not applicable did the device cut? not applicable if yes, was the cut line complete? not applicable if yes, was there any issue with the cut line such as jagged, dull knife, irregular, etc?/ was there any difficulty opening the device? need to use the manual emergency mechanism if yes, how was the device removed from the patient? not applicable 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 ech45c device was returned with no apparent damage and with a gst45b reload loaded on the device.The reload was received partially fired 2/3.In addition, a tyvek was received along with the sample.The manual override door out of position; the override lever was up which denotes that the knife was manually returned to home position.It should be noted after the manual override system is used the instrument is disabled and cannot be used for any subsequent firings.The bailout system was reset and then, the returned device and reload were tested for functionality in the straight position by resetting and reloading it into the device.The device achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the remaining staples met the staple form release criteria.The partially fired is consistent with an incomplete or interrupted cycle.The event described of non specific noise and difficult to open could not be confirmed as the device performed as intended and it opened and closed without any difficulties noted.No abnormal noises were noted during functional testing.The device event log was reviewed.The log indicates that articulation was attempted while the device was closed.Articulation function is blocked when the device is closed to prevent inadvertent patient injury.When the home button is pressed while the jaws are closed the device will attempt to retract the knife.When any of the other articulation buttons are pressed while the jaws are closed the device will provide haptic feedback indicating that articulation function is blocked.The device event log was reviewed.The log indicates that articulation was attempted while the device was closed.Articulation function is blocked when the device is closed to prevent inadvertent patient injury.When the home button is pressed while the jaws are closed the device will attempt to retract the knife.When any of the other articulation buttons are pressed while the jaws are closed the device will provide haptic feedback indicating that articulation function is blocked.In addition, an event was found that typically indicates that the knife encountered the firing safety lockout mechanism.This mechanism ensures that the knife cannot deploy without an unfired reload installed.It is possible that it occurred due to improper installation of the reload.Always ensure that the retaining cap is in place when a reload is installed into a device.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot/batch number, a9817l, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number 571d91, and no non-conformances related to the reported complaint condition 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.
Event or Problem Description
It was reported that during a thoracoscopy procedure, it was observed that the device presented squeaking noise while stapling.It was further reported that the device locked despite reverse and forward motion.Changed to a new one to complete the procedure.There was no patient consequence nor surgical delay reported.No additional information provided.

• Brand Name: ECHELON
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; * 00969 ; 3035526892
• MDR Report Key: 25020173
• Report Number: 3005075853-2026-03185
• Device Sequence Number: 16027991
• Product Code: GDW
• UDI-Device Identifier: 10705036034995
• UDI-Public: (01)10705036034995(17)280430(10)A9817L
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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 Catalogue Number: ECH45C
• Device Lot Number: A9817L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2025
• 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