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

Model Number	EC60
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #p5837v.Investigation summary: the ec60 device was received for analysis with the clamping mechanism damaged and with four cartridge presents.The reloads (b & e) were received partially fired 1/16.The reloads (c & d) were received partially fired 1/3.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 shroud post assembly in the retainer channel was noted to be broken.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.While no conclusion could be reached as to how the clamping mechanism became damaged, it should be noted that 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.
Event or Problem Description
It was reported that during a radical resection of hilar cholangiocarcinoma, before using the device on the patient, the surgeon installed the reload and noted it was difficult to open jaw after closing it.Then the surgeon changed another three reloads (one ecr60b, two ecr60ws), but it was still hard to open the jaw.Another gun was used to complete the procedure.There were no adverse consequences to the patient.No additional information could 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 ; * 00969
• MDR Report Key: 10000867
• Report Number: 3005075853-2020-02348
• Device Sequence Number: 19356077
• 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): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: EC60
• Device Catalogue Number: EC60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2020
• Initial Report FDA Received Date: 04/27/2020
• Patient Sequence Number: 1
• Patient Age: 55 YR