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	10/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # n55z4d.Device evaluation: the sc60 device was received for analysis with no visual non-conformances and with an ecr60b cartridge loaded on the device.The reload was received partially fired 1/16.It is possible that while loading the reload, the cartridge was pushed farther back than the cartridge alignment stop windows resulting in the knife pushing the one piece sled forward and locking the cartridge.The device was tested for functionality in dry fired.However, the firing trigger did not return to its home position after each stroke.The device was disassembled to examine the internal components and the left side release button post was broken, , as the release button was noted to have jammed with the indicator gear.Although the release button is not part of the firing mechanism, when it breaks it creates friction to the firing mechanism not allowing the trigger to properly return to its home position.While there is not enough evidence to conclude what caused the left side release button post to break, it should be noted that a 100% inspection takes place during manufacturing to ensure the device meets the required specifications prior to shipment.The batch history record was reviewed and no protocols or ncr related to the complaint, were found during the manufacturing process.
Event or Problem Description
It was reported that during a laparoscopic gastrectomy, the device was locked out at the first firing when the device was used for ¿duodenum resection.Then, the jaws could not be opened with the anvil release button.Eventually, the jaws could be opened with the button.Another device was used to complete the case.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: 7120473
• Report Number: 3005075853-2017-06801
• Device Sequence Number: 1466698
• Product Code: GDW
• UDI-Device Identifier: 20705036002700
• UDI-Public: 20705036002700
• 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): 10/16/2017

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: 11/22/2019
• Device Catalogue Number: SC60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Initial Date Received by Manufacturer: 11/24/2017
• Initial Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1