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

Catalog Number	ECR60W
Medical Device Problem Codes	Failure to Fire (2610); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) date sent: 03/05/25 d4: batch #unk.Additional information was requested, and the following was obtained: is the current patient status known? good 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 ecr60w with lot number 519c13; 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 clamp slot at the head end of the nail bin was displaced and could not be used after opening the package of the device.There was no patient consequence nor surgical delay reported.Additional information requested.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/1/2025.D4: batch # 482c66.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample revealed that the ecr60w reload was returned unfired with the reload pan partially dislodged from the left proximal side.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.Device history review: a manufacturing record evaluation was performed for the finished device batch number 482c66, and no non-conformances related to the reported complaint condition were identified.
Additional Manufacturer Narrative
(b)(4).Date sent: 4/25/2025.Additional information was requested, and the following was obtained: according to nmpa report ,event description need to be updated: english: would not fire.It was reported that during the surgery, could not fire.Changed the new one to complete surgery.H6.Medical device problem code corrected.
Additional Manufacturer Narrative
(b)(4).Date sent: 5/2/2025.D4 batch #: 482c66.Corrected data: h6, h11.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 revealed that the ecr60w reload was returned unfired with the reload pan partially dislodged from the left proximal side.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 the quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device batch number 482c66, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: WHITE 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: kate karberg ; 475 calle c; guaynabo 00969 ; 3035526892
• MDR Report Key: 21528678
• Report Number: 3005075853-2025-01809
• Device Sequence Number: 18565906
• Product Code: GDW
• UDI-Device Identifier: 10705036001799
• UDI-Public: (01)10705036001799(10)519C13(17)260630
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/01/2025

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: 05/30/2026
• Device Catalogue Number: ECR60W
• Device Lot Number: 519C13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 03/06/2025; 04/25/2025; 04/25/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/01/2025; 04/25/2025; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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