MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 60 LONG; STAPLE, IMPLANTABLE

Catalog Number	LONG60A
Medical Device Problem Codes	Failure to Fire (2610); Difficult to Open or Close (2921); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 05/27/2025.D4: batch # unk.B3: only event year known: 2025.Additional information was requested, and the following was obtained: was the firing sequence started but not completed? if yes: yes, the firing has started but couldn't be finished.The blade was retracted to open the jaws of the device.Did the device deliver any staples? initially yes, it has locked afterwards.If yes, were the staples formed properly? until the device started cutting, the staples were proper.If yes, was the staple line complete? no.The cartridge couldn't be fired fully.Did the device cut? yes, until it is locked.If yes, was the cut line complete? no, it wasn't.If yes, was there any issue with the cut line? due to locking, slight bleeding has occurred.It was taken under control by using another stapler.Was there any difficulty opening the device jaws? a little.There was some difficulty while taken the blade to it's original state.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 # long60a, with lot/batch # x96c5f, and no nonconformances 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 morbid obesity procedure, it was observed that the device locked out.There was no patient consequence nor surgical delay reported.Additional information requested.
Additional Manufacturer Narrative
(b)(4).Date sent: 06/26/2025.D4: batch #149c21.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 the long60a device was received for analysis with no apparent damaged and with an ecr60g reload loaded on the device.The reload was received partially fired 1/4.The device was tested for functionality in the articulated position with the returned reload by resetting and reloading it into the device.The device achieved its complete stroke firing sequence without any difficulties.The staple line and cut line were complete and the remaining staples met the staple form release criteria.The event reported of hemostasis controllable and partial fire were confirmed and it is related to improper use of the device.The partially fired is consistent with an incomplete or interrupted cycle.The event of difficult to open could not be confirmed as the device opened and closed without any difficulties noted.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.Device history review: a manufacturing record evaluation was performed for the finished device batch number 149c21, and no non-conformances were identified.

• Brand Name: ECHELON FLEX 60 LONG
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo 00969 ; 3035526892
• MDR Report Key: 22096049
• Report Number: 3005075853-2025-03946
• Device Sequence Number: 15468951
• Product Code: GDW
• UDI-Device Identifier: 10705036002444
• UDI-Public: (01)10705036002444(10)X96C5F(17)251031
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K081146
• 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
• Report Date (Section B): 05/28/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: LONG60A
• Device Lot Number: X96C5F
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2022
• 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: ECR60G.
• Patient Sex: Unknown