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

Catalog Number	CDH31P
Medical Device Problem Codes	Failure to Fire (2610); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hematoma (1884); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).\ date sent: 9/24/2026.\ d4 batch # unk.\ 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.\ \ the manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.\ \ 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.\ \ attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: \ \ 1.Regarding \" hematoma near the area to be staple\", how was the patient treated/addressed?\ \ 2.Could you please provide more details about the type of oozing (leak, bleeding, other)?\ \ 3.How was the bleeding controlled?\ \ 4.How much blood was lost (ml)?\ \ 5.Did the patient require a transfusion?\ \ 6.How was the bleeding addressed?\ \ 7.Could you please clarify if there were any patient consequences?\ \ 8.Could you please clarify if there were any change in the post-operative care of the patient as a result of the event?.
Event or Problem Description
It was reported that during an unknown surgery when they were about to fire cdh31p, the instrument didn't sound or vibrate.A green check mark appeared but no effect on the tissue were noticed.They tried to change battery by opening another instrument and replacing that battery, but with no change in effect.They took out the instrument and replaced it with a new one, then it worked fine.\ \ was there any reported patient or user harm? yes.\ did the patient/user require any medical or surgical intervention as a result of the event? unknown.\ did the patient/user require extended hospitalization as a result of the event? unknown.\ what is the patient¿s/user¿s status/outcome following the event? hematoma near the area to be stapled during the swap of instruments.\ was there a significant delay? yes.\ how long was the delay (minutes)? 30.

• 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: 50883436
• Report Number: 3005075853-2026-07939
• Device Sequence Number: 10717945
• Product Code: GDW
• UDI-Device Identifier: 10705036015390
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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

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: CDH31P
• Device Lot Number: A99N6C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/20/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2026
• 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