MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GREEN RELOAD FOR ECHELON 60; STAPLE, IMPLANTABLE

Catalog Number	ECR60G
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	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: 07/28/2025.B3: only event year known: 2025.D4: batch #unk.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.D4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.H4: the device manufacture date is currently not available.Additional information was requested, and the following was obtained: - the same problem happened to the other 11 products? please clarify.No, it only happened with two charges, then the surgeons didn't trust the others, so they used another green gst one.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.No lot or batch number was provided; therefore, a device history could not be done.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 wedge resection procedure, it was observed that the metal part of the reload remained in the stapler when removing it.They had to use a tweezer to remove it.There was no patient consequence nor surgical delay reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 08/18/2025.Updated data: h4.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 ten ecr60g reloads were received sterile and with no apparent damage.The returned reloads were opened and tested with a test device.The returned reloads were tested for functionality with a test device in the straight position 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.The event described could not be confirmed as the reloads performed without any difficulties noted.Although the cause of the reported incident could not be determined, proper use of the endo linear cutters - echelon 60mm is important to ensure functionality.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 lot number 429a74, and no non-conformances were identified.

• Brand Name: GREEN RELOAD FOR ECHELON 60
• 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: 22630521
• Report Number: 3005075853-2025-05934
• Device Sequence Number: 15703890
• Product Code: GDW
• UDI-Device Identifier: 10705036001782
• UDI-Public: (01)10705036001782(10)429A74(17)260731
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K051002
• 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): 07/28/2025

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: 07/31/2026
• Device Catalogue Number: ECR60G
• Device Lot Number: 429A74
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• 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