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

Catalog Number	PCEE45A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 5/6/2026.D4: batch #203d30.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: please explain in detail what was the issue with the device.Was the firing sequence started but not completed? if yes: did the device deliver any staples? if yes, were the staples formed properly? if yes, was the staple line complete? did the device cut? if yes, was the cut line complete? if yes, was there any issue with the cut line such as jagged, dull knife, irregular, etc? was there any difficulty opening the device? if yes, how was the device removed from the patient? if yes, did the jaws eventually open? is the current patient status known? was there any patient consequence or change in the post-operative care of the patient as a result of the event? 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 pcee45a 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.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 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 meet the staple release criteria.However, the knife was noted to have nicks.One possible cause for this type of damage to the knife is when the device is fired over an already existing staple line, hard object, or thicker tissue than indicated.Repeatedly firing across existing staple lines can also reduce the ability to cut cleanly.To mitigate the potential for staples getting into the reload and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and reload jaw in sterile solution and then wipe the anvil and reload jaw to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.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 pcee45a, with lot/batch number c9ew17, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number 203d30, and no non-conformances related to the reported complaint condition 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 laparoscopic gastric bypass procedure, the endostapler presented a defect / locking in the stapling, and it was necessary to replace it with a new endostapler.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: 25097226
• Report Number: 3005075853-2026-03436
• Device Sequence Number: 9959745
• Product Code: GDW
• UDI-Device Identifier: 10705036015338
• UDI-Public: (01)10705036015338(17)270731(10)C9EW17
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K163454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: PCEE45A
• Device Lot Number: C9EW17
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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