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

Catalog Number	ECR45W
Medical Device Problem Codes	Failure to Form Staple (2579); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 07/10/2025 d4: batch #unk.Additional information was requested, and the following was obtained: was there any other issue noted with the staple line other than bleeding (malformed staples, staple line missing staples, etc.)? malformed staples how was the bleeding controlled? suture sewing how much blood was lost (ml)? unknown did the patient require a transfusion? no is the current patient status known? discharged was there any patient consequence or change in the post-operative care of the patient as a result of the event? no a manufacturing record evaluation was performed for the finished device ecr45w with lot number 963a39; 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, the device was used to disconnect the left inferior pulmonary vein.After disconnecting the left inferior pulmonary vein, it was found that the nail edge at the distal end of the vein was not fully closed, resulting in bleeding.Changed to a new one to complete the procedure.There was no patient consequence nor surgical delay reported.Additional information requested.
Additional Manufacturer Narrative
(b)(4).Date sent: 09/06/2025 an analysis of the product could not be performed since a physical sample was not received for evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.However, if the product is received at a later date, the investigation will be updated as applicable.

• 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: 22470941
• Report Number: 3005075853-2025-05407
• Device Sequence Number: 20829689
• Product Code: GDW
• UDI-Device Identifier: 10705036001768
• UDI-Public: (01)10705036001768(10)963A39(17)270831
• 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): 07/10/2025

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: ECR45W
• Device Lot Number: 963A39
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 08/31/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 09/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/06/2022
• 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