MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 45 COMPACT; STAPLE, IMPLANTABLE

Catalog Number	SC45A
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unk procedure, when the surgeon trigger the endo cutter, the staple couldn't pass the tissue and stop.In the end, the surgeon use another endo cutter to staple the tissue.The surgery was not delayed and was completed successfully.No patient consequences were reported.
Additional Manufacturer Narrative
(b)(4), date sent: 10/27/2023, d4: batch # 943a66, b3: exact event date unk, entered 1/1/2023 as only the year was provided.Investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that the sc45a device was returned disassembled along with some components inside a plastic bag.The device had the jaws and closure trigger in the closed position, the anvil knife slot damaged, and with a gst60t reload loaded on the device.The reload was received partially fired 3/4 with the cartridge deck damaged.No functional test was performed due the condition.After further evaluation, the anvil could not be opened.No functional test could be performed due to the condition of the device.The device was disassembled to verify the integrity of the internal components and the knife was noted to be buckled.The event reported was confirmed and it is related to improper use of the device.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond indicated thickness or tissue that cannot compress to the indicated range for the selected cartridge.This may have caused excessive force to be applied to the underside of the solid steel anvil leading to this damage.It should be noted that a 100% inspection takes place during manufacturing to ensure the device meets the required specifications prior to shipments, in addition, a sample of the batch is inspected at finished good quality assurance.The damage to the knife is consistent with the device being clamped over an excess of tissue.If the firing continues the knife will buckle, and as the knife is attempting to pull the anvil towards the reload to form the staples it will result in the damage observed on the anvil.The damage to the reload is consistent with the device being clamped over a hard object.To mitigate the potential for staples getting into the reload and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and reload jaw in sterile solution and then wipe the anvil and reload jaw to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.Please reference the instruction for use for more information.Device history review a manufacturing record evaluation was performed for the finished device batch number 943a66, and no non-conformances were identified.

• Brand Name: ECHELON FLEX 45 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: 18021329
• Report Number: 3005075853-2023-07934
• Device Sequence Number: 15116059
• Product Code: GDW
• UDI-Device Identifier: 10705036002697
• UDI-Public: 10705036002697
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 10/27/2023

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: 02/28/2026
• Device Catalogue Number: SC45A
• Device Lot Number: A9CL8Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2023
• Initial Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown