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	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lung volume reduction procedure, the stapler locked to open, and it was necessary to force the opening of the handle.In the tissue there was partial stapling with the green load that stapled to half, and later with the black load stapled 1/3 of the load.It was necessary to change the stapler to continue and complete the procedure.There was no patient consequence nor surgical delay reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4) date sent: 10/13/2025 b3: only event month and year known: september 2025 d4: batch #unk.Additional information was requested, and the following was obtained: 1.Was the firing sequence started but not completed? yes, twice, but the stapler jammed more times before that.If yes: 2.If yes, were the staples formed properly? in the part that was stapled, the staples formed correctly, but the entire load was not stapled.3.If yes, was the staple line complete? no 4.Did the device cut? in the part that was stapled, it cut.5.If yes, was the cut line complete? the cut was complete in the part that was stapled.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 was performed for the finished device ech45l lot number a97p94 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: 11/05/2025.D4: batch #854c58.Corrected data: d4 (udi, expiration date), 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.Additionally, a photo was provided and it showed a tyvek.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.The manual override door was noted to be 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, 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 event described could not be confirmed as no reload was received and the device performed as intended and it opened and closed without any difficulties noted.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 batch number 854c58, and no non-conformances related to the reported complaint condition 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: 23280844
• Report Number: 3005075853-2025-07990
• Device Sequence Number: 8808989
• Product Code: GDW
• UDI-Device Identifier: 10705036034964
• UDI-Public: (01)10705036034964(10)A97P94(17)270228
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2025

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: A97P94
• 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: 09/26/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GST45G; GST45T
• Patient Age: 66 YR
• Patient Sex: Female