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

Catalog Number	ECH45C
Medical Device Problem Codes	Failure to Fire (2610); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 3/31/2026.D4: batch#: a97z2l.Additional information was requested, and the following was obtained: please provide more details for "there were no sleds", the sled esd missing.2.Were there staples in the reload prior to firing? unk.3.When the device fired, were there no staples deployed? no.4.Did the cartridge presented any physical damage? unk 5.Was the plastic portion of the cartridge damaged? unk.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 gst45g reload present.The reload was received with the one-piece sled missing and unfired, with the reload pan partially dislodged from the left proximal side.In addition, 2 double drivers out of position, making the reload non-functional.Additionally, the ech60r buttress was on the reload deck and on the anvil.The buttresses were received with visible degradation/flaking due to previous exposure, the time out of foil packaging, and the decontamination process, the integrity of the absorbable materials could not be assessed and therefore no further testing could be conducted.The device 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.No conclusion could be reached on what may have caused the reload pan to dislodge.It is possible that when removing the staple retainer in an upward and distal to proximal sliding manner prior to loading the reload into the device it can eject the sled from the proximal end of the reload.The ifu instruct the user to leave the staple retainer in position until the reload is loaded into the device.The event log was reviewed.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.Additionally, photo was provided and they showed a device 45 mm and with a green reload with ech60r buttress was on the reload deck.As part of our quality process, the manufacturing records of this batch number were reviewed, and the manufacturing standards were met prior to the release of this batch.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: a97z2l, and no non-conformance's 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 an unknown open respiratory procedure, it was observed that the device was locked out at the 2nd firing when resecting the lung.Apparently, there were no sleds attached.The cartridge color was blue.Another device was used to complete the case.There were no adverse consequences to the patient.No additional information was 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: 24746612
• Report Number: 3005075853-2026-02415
• Device Sequence Number: 13091012
• Product Code: GDW
• UDI-Device Identifier: 10705036034995
• UDI-Public: (01)10705036034995(10)A97Z2L(17)280430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: A97Z2L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ECH60R.; GST45B.
• Patient Sex: Unknown