MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 60 COMPACT; STAPLE, IMPLANTABLE

Catalog Number	SC60A
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
it was reported that during a gastric procedure surgery, could not fire.Changed another reload to continue the surgery, the same problem happened.Another device was used to complete the procedure.There was no patient consequence reported.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Date sent 10/14/2024 d4 batch #435c42 investigation summary the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the sc60a device was returned with the jaws and closure trigger in the closed position.Also, the knife was noted partially advance, the red manual knife reverse button was activated and the knife returned to the home position as expected and one ecr60d reload loaded and a second ecr60d (b) reload present.The reload loaded was received fully fired.The reload (b) was received unfired with the pan partially dislodged from the left proximal side and 8 double drivers missing.The device was tested for functionality in the straight position with a test reload and achieved its complete stroke firing sequence without any difficulties.The cut line was complete and the remaining staples meet the staple form release criteria.The condition of the knife advanced noted on the device, should be noted that in order to fully return the knife to its home position the fourth stroke must be completed.No conclusion could be reached on what may have caused the reload pan to dislodge.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.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 435c42, and no non-conformances were identified.A manufacturing record evaluation was performed for the finished device sc60a lot number a9d43j and no non-conformances were identified.

• Brand Name: ECHELON FLEX 60 COMPACT
• 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: 20439028
• Report Number: 3005075853-2024-07708
• Device Sequence Number: 18188629
• Product Code: GDW
• UDI-Device Identifier: 10705036002710
• UDI-Public: (01)10705036002710(17)260430(10)A9D43J
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081146
• 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): 10/14/2024

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: 04/30/2026
• Device Catalogue Number: SC60A
• Device Lot Number: A9D43J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2024
• Initial Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ECR60D(X2)
• Patient Sex: Unknown