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	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # r58c23.Additional information was requested, and the following was obtained: was there difficulty closing the jaws of the device? no.Was there difficulty opening the jaws of the device? did not open the jaw as last, not difficult to open the jaw.If yes, how was the device removed (anvil release button, red manual knife switch, jaws forced open, cut from tissue, etc.) as did not clamp the tissue, so removed the device from trocar.Did the jaws eventually open? no.Device analysis: the analysis results showed that one ec60 device was returned with no visual non-conformance's and with an ecr60b fully fired reload not loaded on the device.The device was tested for functionality with a test reload and it achieved a complete 3-strokes fire without any difficulties noted.The device fired, cut and formed all the staples as intended.The staple line and cut line were complete and the staples meets the staple release criteria.The event described could not be confirmed as the device performed as intended and it opened and closed without any difficulties noted.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance's were identified.
Additional Manufacturer Narrative
(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.
Event or Problem Description
It was reported that during the radical gastrectomy for gastric cancer surgery, after inserting into trocar, did not clamp the tissue, so removed the device from trocar.There was no difficulty closing the jaws of the device.Found could not open the jaw and the jaws of device never eventually opened.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: 9014685
• Report Number: 3005075853-2019-21961
• Device Sequence Number: 398331
• 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,Followup
• Report Date (Section B): 08/19/2019

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: 06/30/2023
• Device Catalogue Number: EC60
• Device Lot Number: R93W5V
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 10/04/2019
• Patient Sequence Number: 1