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

Catalog Number	ECR60D
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 12/15/2025.D4: batch #unk.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 device ecr60d with lot number 262c72; 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 staples were malformed after firing.Changed to another one to continue the procedure but the same problem happened again.Changed to a new one to complete the procedure.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent 1/7/2026.D4 batch #987a84.Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample determined that one ecr60d reload was received unfired without detectable damage.The returned reload was loaded into a test device, tested for functionality 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 no malformed staples were observed and the reload was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during use that could not be replicated during laboratory analysis.As part of ees quality process all devices are manufactured, inspected, and released to approved specifications.Based on the results of this investigation , it was determined that the product met the manufacturing release criteria: a manufacturing record evaluation was performed for the finished device batch number 987a84, and no non-conformances were identified.

• Brand Name: GOLD 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: 23809224
• Report Number: 3005075853-2025-09528
• Device Sequence Number: 9297514
• Product Code: GDW
• UDI-Device Identifier: 10705036011842
• UDI-Public: (01)10705036011842(10)262C72(17)271231
• 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,Followup
• Report Date (Section B): 01/07/2026

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: 262C72
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2022
• 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