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

Model Number	ECR45M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unk.Date of event is 2022, event day and month unknown.Captured as (b)(6) 2022.Investigation summary: the product was returned to ethicon endo-surgery cincinnati for evaluation.Visual inspection and functional testing were conducted on the returned reload.Visual analysis of the returned sample determined that one ecr45m reload was received unfired.Upon evaluation of the reload was noted to have double-loaded staples in every staple pocket.The returned reload was loaded into a test device.The reload was fired in tissue and produced a mix of conforming and nonconforming staples.However, these staples do not create a fluid path.Based on the information currently available, a product issue was identified during the investigation of the sample received.The double staples observed are potentially related to a manufacturing process.This product issue will be addressed through ethicon endo surgery¿s quality system.A manufacturing record evaluation was performed for the finished device lot number u40t65, and no non-conformances were identified.
Event or Problem Description
It was reported by employee that during a preformed scans, double loaded cartridge.There were no patient consequences reported.

• Brand Name: GRAY RELOAD FOR 45MM ECHELON
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16375210
• Report Number: 3005075853-2023-00983
• Device Sequence Number: 7543804
• Product Code: GDW
• UDI-Device Identifier: 10705036001751
• UDI-Public: 10705036001751
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2023

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: 11/30/2025
• Device Model Number: ECR45M
• Device Catalogue Number: ECR45M
• Device Lot Number: U40T65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown