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

Catalog Number	EC60
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r58c23.Additional information was requested and the following was obtained: to confirm, the reported product code is ec60, but the event description could be referring to a powered echelon device.Is ec60 the correct product code? if not, what is the correct product code? yes, it is ec60.The event description shows knife reverse button, it means manual override lever.Device analysis: the analysis results found that one ec60 device was returned with no apparent damage and with no cartridge reload present.The device was tested for functionality with a test cartridge reload and achieved its complete 3-stroke firing sequence without any difficulties.The staple line and cut line were complete and the staples meets the staple release criteria.However, the cut was noted to be jagged due to a damaged knife.One possible cause for this type of damage to the knife is when the device is fired over an already existing staple line, hard object or thicker tissue than indicated.Repeatedly firing across existing staple lines can also reduce the ability to cut cleanly.To mitigate the potential for staples getting into the cartridge and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and cartridge jaw in sterile solution and then wipe the anvil and cartridge 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.As part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.The device opened and closed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
Would not reverse knife.It was reported that during the endoscopic lobectomy surgery, after fired, the knife moved to the distal end, but could not return knife automatically.Used knife reverse button to return knife.There were no adverse consequences to the patient.No additional information can be provided.

• Brand Name: ECHELON 60 ENDOPATH STAPLER
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9104960
• Report Number: 3005075853-2019-22261
• Device Sequence Number: 16180755
• Product Code: GDW
• UDI-Device Identifier: 10705036001690
• UDI-Public: 10705036001690
• Combination Product (Y/N): N
• PMA/510(K) Number: K051002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2019

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: 05/30/2021
• Device Catalogue Number: EC60
• Device Lot Number: R93W5V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/23/2019
• Patient Sequence Number: 1