MAUDE Adverse Event Report: Ethicon Endo-Surgery, LLC. ECHELON CIRCULAR; STAPLE, IMPLANTABLE

Catalog Number	CDH25P
Medical Device Problem Codes	Failure to Fire (2610); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a low anterior resection procedure, abnormal sound was detected and could not fire.Besides, cut washer was detached.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent 8/10/2026.D4 batch # unknown.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.An analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.No lot or batch number was provided therefore a device history could not be done.Photo analysis: this is an analysis of a photo submitted for evaluation.During the visual analysis, the following was observed: the photo shows a device with the trocar extended and the washer can be seen completely cut, the knife and the drivers expose, also 2 donuts could be observed on the shaft of the anvil.Based on the photo the event described cannot be confirmed.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.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 CIRCULAR
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer (Section G): Ethicon Endo-Surgery, LLC.; 475 calle c; guaynabo 00969 ; PR 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; PR ; +1(303)552-6892
• MDR Report Key: 50197083
• Report Number: 3005075853-2026-06465
• Device Sequence Number: 14833117
• Product Code: GDW
• UDI-Device Identifier: 10705036015376
• UDI-Public: 10705036015376
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K163523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: CDH25P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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