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

Catalog Number	ECR60D
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 10/20/2025 d4: batch #unk.Additional information was requested, and the following was obtained: did the device deliver any staples? yes if yes, were the staples formed properly? yes if yes, was the staple line complete? no did the device cut? yes if yes, was the cut line complete? no was there any difficulty opening the device? no.A manufacturing record evaluation was performed for the finished device ecr60d with lot number 314c50; 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.
Event or Problem Description
It was reported that during an unknown procedure, it was observed that the device could not fire farther after fired a little.Changed to a new one to complete the procedure.There was no patient consequence nor surgical delay reported.No additional information provided.

• Brand Name: GOLD RELOAD FOR ECHELON 60
• 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: 23337586
• Report Number: 3005075853-2025-08134
• Device Sequence Number: 7807848
• Product Code: GDW
• UDI-Device Identifier: 10705036011842
• UDI-Public: (01)10705036011842(10)314C50(17)280131
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

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: ECR60D
• Device Lot Number: 314C50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2023
• 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