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

Catalog Number LONG60A

Device Problems Defective Component (2292); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.Incident occurred before use, it was impossible to open the device and staple.It occurred at the first firing.We don¿t have more information.

Event Description

It was reported that during a laparoscopic sleeve gastrectomy procedure, the open/close function of the device was defective, it was impossible to staple.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

Manufacturer Narrative

(b)(4).Batch # n53w62.The long60a device was received for analysis with no visual non-conformances and with an ecr60g cartridge loaded on the device.The cartridge 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.It should be noted that in order to open a device that has been partially fired or fully fired a reverse stroke needs to be performed trigger to trigger to handle in order to return the knife to the home position (indicator in the "0" position) and press the anvil release button to open.The returned device and cartridge reload were tested for functionality in the articulated position by resetting and reloading it into the device.The device achieved its complete stroke firing sequence without any difficulties.The staple line and cut line were complete and the staples were noted to have the proper b-form shape.The event could not be confirmed as the device closed and opened as intended.

• Brand Name: ECHELON FLEX ENDOCUTTER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5792179
• MDR Text Key: 50189791
• Report Number: 3005075853-2016-03946
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081146
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/01/2016

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: 02/08/2019
• Device Catalogue Number: LONG60A
• Device Lot Number: N90T05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2016
• Initial Date FDA Received: 07/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1