MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON LINEAR CUTTER; STAPLE, IMPLANTABLE

Catalog Number EC60A

Device Problems Crack (1135); Difficult to Open or Close (2921)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 01/14/2015

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic hand assisted radical nephrectomy procedure, the device was fired and would not open from the tissue.This occurred on the first firing with a white cartridge.The reverse function was activated and the device still would not open.The device did cut and staple.It was noted the black handle was cracked.At the time of the call, the device was still stuck on tissue and the procedure was in progress.There was no patient consequence reported at this time.

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date, a supplemental medwatch will be sent.Additional information was requested and the following was obtained: this surgeon is a new ethicon surgeon at the account and is not as experienced with the device.The device was being used on the renal vein with a small branch included with the tissue in the jaws.The device was fired by completing three firing strokes and on the fourth stroke the knife only returned ¾ of the way.The device would not open.The user attempted to squeeze the firing trigger again with no response.The reverse switch was activated and did not work.The switch was noted to be floppy.The user then tried to pull on the closing trigger to open the jaws and the closing trigger broke from the device.Another device was opened and used to transect around this device and remove it from the patient.There was no patient consequence or change in the procedure as a result of the event.The device is still closed with tissue inside the jaws.

Manufacturer Narrative

(b)(4).Additional information: closing trigger.The analysis found that one ec60a device was returned with the closure trigger broken and with one ecr60w cartridge loaded in the device.The cartridge reload was received fully fired.Upon opening of the device, the returned reload was noted to have a clip on cartridge deck.In addition the cartridge deck was found damaged.To mitigate the potential for staples getting into the cartridge and interfering with the knife path during device firing, prior to reloading the device, rinse the anvil and cartridge jaw in sterile solution and then wipe the anvil and cartridge jaw to clean any formed but unused staples from the device.Additionally, proper care should be taken when placing the device on the tissue to be stapled, to ensure that no hard obstruction such as a clip is included with the tissue inside the jaws.Firing the device with a clip in the jaws can jam the firing mechanism resulting in the device not opened.No further functional testing could be performed due to the condition of the device.The device history records were reviewed and the manufacturing criteria was met prior to the release of the device.

• Brand Name: ECHELON LINEAR CUTTER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4455763
• MDR Text Key: 5428363
• Report Number: 3005075853-2015-00708
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2019
• Device Catalogue Number: EC60A
• Device Lot Number: L90P1A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2015
• Initial Date FDA Received: 01/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RELOAD ECR60W