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

Catalog Number	PLEE60A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	Failure to Anastomose (1028)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 4/22/2026.D4: batch #unk.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: were there any patient consequences? did the post op care change in any way due to the event issues during the surgery? if yes, how? did this event occur in the same procedure or different procedures? in what year did the patient have the gastric sleeve procedure completed? when the ed states ¿we were called back into the or after a few minutes ¿.Who is ¿we¿? did the patient have to have a modified surgical procedure due to this event? 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 evaluation was performed for the finished #plee60a, with lot/batch #a9860vr, 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.
Event or Problem Description
It was reported that during a sleeve to gastric bypass conversion procedure, it was observed that the staple line was completely formed during the gastro-entero anastomosis.However, after a few minutes it appeared that the staple line had opened up.Upon inspection of the staple line, it indeed appeared like a gap was present.The proximal part of the staple line was properly formed, as was the distal portion (small part).However, it seemed that no staples were present (the staple line was not formed) in between.Upon inspection of the reload that was used, drivers were visible across the reload.There was no adverse consequences reported.No additional information was provided.

• Brand Name: ECHELON FLEX
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; 3035526892
• MDR Report Key: 24954659
• Report Number: 3005075853-2026-03035
• Device Sequence Number: 10084700
• Product Code: GDW
• UDI-Device Identifier: 10705036014614
• UDI-Public: (01)10705036014614(17)261031(10)A9860VR
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K110385
• 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
• Report Date (Section B): 04/22/2026

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: PLEE60A
• Device Lot Number: A9860VR
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: 04/30/2026; 05/18/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/08/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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: GST60W X5.
• Patient Sex: Unknown