MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. GREEN RELOAD FOR ECHELON 45; STAPLE, IMPLANTABLE

Catalog Number	ECR45G
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, they opened the packing and noted that some staples fell off.Changed to a new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent: 10/14/2025.D4: batch #855a69.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 revealed that the ecr45g reload was returned fully fired with the reload pan partially dislodged and damaged (scratches) from the left proximal side.In addition, 5 double driver were missing with staples in the pockets, making the reload non-functional.In addition, an opened package was received along with the reload.No functional test was performed due the condition of the reload.No conclusion could be reached on what may have caused the reload pan to dislodge.As part of our quality process, the manufacturing records of this batch number were reviewed, and the manufacturing standards were met prior to the release of this batch.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 ecr45g with lot number 928a09; and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device batch number 855a69, 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.

• Brand Name: GREEN RELOAD FOR ECHELON 45
• 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: 23290592
• Report Number: 3005075853-2025-08014
• Device Sequence Number: 4889918
• Product Code: GDW
• UDI-Device Identifier: 10705036001744
• UDI-Public: (01)10705036001744(10)928A09(17)250630
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/14/2025

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: 06/30/2025
• Device Catalogue Number: ECR45G
• Device Lot Number: 928A09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2022
• 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
• Patient Sex: Unknown