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

Catalog Number	LONG60A
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 10/17/2025 d4: batch #475d66 additional information was requested, and the following was obtained: was the firing sequence started but not completed? if yes: did the device deliver any staples? yes if yes, were the staples formed properly? yes if yes, was the staple line complete? yes did the device cut? it cut when it didn¿t block.If yes, was the cut line complete? yes if yes, was there any issue with the cut line such as jagged, dull knife, irregular, etc? no was there any difficulty opening the device? yes after blocked if yes, how was the device removed from the patient? yes if yes, did the jaws eventually open? yes 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: 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? (extended hospital stay, readmission, re-operation, etc.) 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 three gst60g reload present.The reload b&c were received partially fired 1/3.The reload d was received partially fired 2/3.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 could not be confirmed as the device opened and closed without any difficulties noted.The condition of the reloads are related to improper use of the device.The partially fired is consistent with an incomplete or interrupted cycle.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 batch number 475d66, 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 bariatric procedure, it was observed that the stapler was blocked.There was no patient consequence nor surgical delay reported.No additional information provided.

• Brand Name: ECHELON FLEX 60 LONG
• 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: 23323916
• Report Number: 3005075853-2025-08091
• Device Sequence Number: 16106109
• Product Code: GDW
• UDI-Device Identifier: 10705036002444
• UDI-Public: (01)10705036002444(10)475D66(17)280228
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2025

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 Catalogue Number: LONG60A
• Device Lot Number: 475D66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2025
• 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
• Patient Sex: Unknown