MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON FLEX 45 LONG; STAPLE, IMPLANTABLE

Catalog Number	EC45AL
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Batch # r5956e.Investigation summary: the analysis found that one ec45al device was returned with the closure trigger broken and in the closed position, and with one gst45w cartridge loaded in the device.The cartridge reload was received fully fired and with damage on cartridge deck.After further analysis the articulation mechanism was noted to be damaged as would not hold the articulation setting.In addition, the knife was noted to be buckled.No functional test was performed due the condition of the device.The damage to the device and cartridge it is possible that the device was clamped over an excess of tissue or a hard object, resulting in the damage to the closure trigger handle, knife and cartridge.As part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure that the device meets the required specifications prior to shipment.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.Please clarify "there was possible injury to the ureter": was it determined if there was any damage to ureter? if so, please explain.To confirm, did the device lock-out (no staples deployed and no cut line started)? or, did the device start to deploy staples and cut but could not be completed (partially fire)? or, did the device fully fire and stop during the automatic knife return? was there any difficulty opening the device? if yes, how was the device removed from the patient? if yes, did the jaws eventually open?.
Event or Problem Description
It was reported that during a robotic prostatectomy, while taking the dorsal venus complex, the stapler, with white reload, no buttressing material, locked on tissue.The stapler was removed from tissue by using the robot arm to separate the jaws.The procedure was completed using suture.There was possible injury to the ureter but no other patient consequences were reported.

• Brand Name: ECHELON FLEX 45 LONG
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8405617
• Report Number: 3005075853-2019-17109
• Device Sequence Number: 19313468
• Product Code: GDW
• UDI-Device Identifier: 10705036001683
• UDI-Public: 10705036001683
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K051002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2019

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: 05/30/2021
• Device Catalogue Number: EC45AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/08/2019
• Patient Sequence Number: 1