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

Catalog Number	SC60
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # p5706u.Device evaluation: the analysis results found that one sc60 device was returned with the firing mechanism damaged.No functional test could be performed due to the condition of the device.The device was disassembled to verify the condition of the internal components and firing shuttle was noted to be separated from the pawl, causing the firing mechanism not to properly operate.The device opened and closed without any difficulties noted.This damage is consistent with high (outside indicated use) forces applied to the firing mechanism possible due to thicker tissue then indicating or attempting to fire a partially fired or a fully fired reload.It should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the require specifications prior to shipments, in addition, a sample of the batch is inspected at fgqa.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that could not return blade.During the endoscopic pulmonary bullae, after fired, could not return the blade, used manual release lever to return the blade.There were no adverse consequences to the patient.

• 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: 8000989
• Report Number: 3005075853-2018-13922
• Device Sequence Number: 13495230
• Product Code: GDW
• UDI-Device Identifier: 10705036002703
• UDI-Public: 10705036002703
• 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): 08/24/2018

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: 05/20/2020
• Device Catalogue Number: SC60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1