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

Catalog Number	PCEE60A
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 5/14/2026.D4: batch #887d27.Additional information was requested, and the following was obtained: what is meant by "the safety mechanism"? was the manual override lever or door damaged in any way? was there any damage to the firing/closing trigger? if other, please specify.Per the sales rep: my understanding was the safety near the trigger to fire was the issue.The manuals override was not used and no other damage seemed visible.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 pcee60a device was returned with no apparent damage and with no reload present.Upon analysis, the jaws and closure trigger were noted in the close position, the knife was noted to be slightly advanced.The knife reverse switch was activated and the knife returned to the home position as expected.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.It is possible that the knife advanced into anvil noted on the device was due to improper handling resulting on the device not been able to open.The event described of damaged firing trigger lockout could not be confirmed as the firing trigger lockout functioned as intended and without any difficulties noted.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 lot/batch number, a99k0j, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number 887d27, 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 minimally invasive esophagectomy procedure, after the device was fired once, the safety mechanism was no longer functional, preventing proper engagement of the safety feature.There was no patient consequence nor surgical delay reported.No additional information provided.

• Brand Name: ECHELON FLEX
• 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: 25175058
• Report Number: 3005075853-2026-03645
• Device Sequence Number: 13403546
• Product Code: GDW
• UDI-Device Identifier: 10705036015017
• UDI-Public: (01)10705036015017(17)290131(10)A99K0J
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: PCEE60A
• Device Lot Number: A99K0J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2026
• 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