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

Catalog Number	ECR45W
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date sent: 1/2/2026.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 ecr45w lot number 225c35; 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 a lobectomy procedure, it was observed that the closed staples unraveled when vessel was closed intraoperatively.Changed to a new one to complete the procedure.There was no patient consequence nor surgical delay reported.No additional information provided.
Additional Manufacturer Narrative
(b)(4).Date sent 1/8/2026.D4 batch #983a57.Investigation summary: the product was returned for thorough evaluation, which included visual inspections and functional testing of the returned device.Visual analysis of the returned sample determined that one psee45a device was returned with joint cover damaged and with an ecr45w reload present.The reload was received fully fired.The device was tested for functionality in the straight position with a test reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples meet the staple release criteria.No functional test could be performed due to the condition of the reload.The damage on the device joint cover, it is possible that the device was attended to be pulled out from a trocar in the articulated position, resulting in the edge of the trocar damaging the joint cover.Please reference the instruction for use for more information.The event described could not be confirmed as the device performed without any difficulties noted and the reload was received fully fired.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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 983a57, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: WHITE RELOAD FOR ECHELON 45
• 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: 23949789
• Report Number: 3005075853-2026-00031
• Device Sequence Number: 13442861
• Product Code: GDW
• UDI-Device Identifier: 10705036001768
• UDI-Public: (01)10705036001768(10)225C35(17)271130
• 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,Followup
• Report Date (Section B): 01/08/2026

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: ECR45W
• Device Lot Number: 225C35
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/04/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2022
• 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