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	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: the ec60 device was received for analysis with no visual non-conformance's and with an ecr60d cartridge loaded on the device.The reload was received partially fired 1/16.The device was tested for functionality with the returned cartridge reload by resetting and reloading it into the device.The functional test demonstrated that the instrument achieved its complete 3-stroke firing sequence without any difficulties.However, when tested with the returned reload only left side was fully fired and the right side only fired the outer row.The cartridge was disassembled and was noted that the one piece sled to be damaged.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.
Event or Problem Description
It was reported that during an unknown procedure, the echelon flex did not fire.The reload was placed properly.The reverse button was used but it went difficult.No patient consequences; they took another ec60 to complete the procedure.

• 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: 8787002
• Report Number: 3005075853-2019-20387
• Device Sequence Number: 1993580
• 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): 06/20/2019

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: 01/28/2021
• Device Catalogue Number: EC60
• Device Lot Number: R92P63
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/12/2019
• Patient Sequence Number: 1