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

Catalog Number	ECR45B
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown surgery, could not fire.Changed the new one to complete surgery.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent 1/26/2026.D4 batch #277c25.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 ecr45b reload was returned unfired with an open package, with the reload pan detached.In addition, 4 double driver out of position, 4 double drivers missing and 1 single driver missing making the reload non-functional.No functional test was performed due the condition of the reload.It is also possible that handling by the customer could dislodge the pan.Dislodgement as a result of the removal of the reload from the device is the most likely scenario.Please reference the instruction for use for more information.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 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 277c25, and no non-conformances were identified.

• Brand Name: BLUE RELOAD FOR ECHELON 45
• 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 ; * ; 3035526892
• MDR Report Key: 24177494
• Report Number: 3005075853-2026-00791
• Device Sequence Number: 9524155
• Product Code: GDW
• UDI-Device Identifier: 10705036001720
• UDI-Public: (01)10705036001720(17)280131(10)330C50(21)
• 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
• Report Date (Section B): 01/26/2026

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: ECR45B
• Device Lot Number: 330C50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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