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	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.
Event or Problem Description
It was reported that during the thoracoscopic resection of right middle pulmonary nodule surgery, after fired, the knife moved to the distal end, but would not return knife automatically.Knife reverse button would not work.Used another device to remove the ec60 from the patient.There were no adverse consequences to the patient.No additional information can be provided.
Additional Manufacturer Narrative
(b)(4).Batch # r57y6t.Investigation summary: the ec60 device was returned with the closing trigger and anvil closed.An ecr60b cartridge was received loaded on the device.The reload was received fully fired.The device has disassembled and was noted to be a clip was found lodged behind the knife, resulting in the firing mechanisms jamming.No functional test was performed due the condition of the device.When placing the instrument on the tissue to be stapled, ensure that no hard obstruction (such as a clip) is included with the tissue inside the jaws.Please reference the instruction for use for warnings and precaution regarding firing across hard objects.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

• 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: 8680774
• Report Number: 3005075853-2019-19555
• Device Sequence Number: 16686539
• 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): 05/14/2019

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: 05/17/2021
• Device Catalogue Number: EC60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 07/15/2019
• Patient Sequence Number: 1