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	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch: r57y6t.Investigation summary: the ec60 device was received for analysis with no visual non-conformances and with an ecr60w cartridge loaded on the device.The reload was received partially fired and with damage on cartridge deck.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 were noted to have the proper b-form shape.It is possible that the combination of tissue and/or buttressing material compressed between the device jaws may have been beyond indicated thickness.This may have prevented the top of the knife blade assembly from entering into the anvil.The damage to the cartridge is consistent with the device being clamped over a hard object.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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.
Event or Problem Description
It was reported that during the laparoscopic gastrectomy surgery, could not fire.Changed the new one to complete surgery.There was no patient consequence reported.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: 8627782
• Report Number: 3005075853-2019-19241
• Device Sequence Number: 2211919
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2019

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: 03/17/2021
• Device Catalogue Number: EC60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1