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

Catalog Number	ECH45C
Medical Device Problem Codes	Failure to Form Staple (2579); No Apparent Adverse Event (3189); Firing Problem (4011)
Health Effect - Clinical Codes	Pneumothorax (2012); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, it was observed that the knife moved forward for a moment, but then repeatedly stopped and moved forward, and the knife did not move forward easily at the first firing after opening the package and while transecting the bronchus.When reaching the tip of the jaw and returning, the knife returned the same movement, with repeatedly stopped and moved forward.After opening the jaw and checking the staples, the staples were malformed.The cartridge color was white.Another device was used to complete the case.There were no adverse consequences to the patient.No additional information provided.
Additional Manufacturer Narrative
(b)(4) date sent: 4/13/2026 b3: unknown d4: batch #unk d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H4: the device manufacture date is currently not available.Additional information was requested, and the following was obtained: the procedure was thoracoscopic lobectomy.The staple formation style could not be clearly confirmed.At the time of the event, an air leak from the bronchus was observed.The area where staples could not be properly formed was additionally sutured with sutures.No change in the surgical procedure was required during additional suturing.As of the day after surgery, the patient¿s condition is stable.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.No lot or batch number was provided; therefore, a device history could not be done.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.

• Brand Name: ECHELON
• 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: 24865027
• Report Number: 3005075853-2026-02788
• Device Sequence Number: 10493687
• Product Code: GAG
• UDI-Device Identifier: 10705036034995
• UDI-Public: (01)10705036034995(17)280730(10)A98H8T
• 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,Followup,Followup,Followup
• Report Date (Section B): 05/28/2026

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: A98H8T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 04/21/2026; 05/20/2026; 07/08/2026
• Initial Report FDA Received Date: 04/13/2026
• Supplement Report FDA Received Date: 05/18/2026; 05/28/2026; 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2025
• 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: GST45D; VASECR35
• Patient Sex: Unknown