MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON*FLEX60 LONG ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60 MM; STAPLE, IMPLANTABLE

Catalog Number LONG60A

Device Problem Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 03/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot/batch.Additional information requested and received: what was the procedure? gastrectomy.What were the indications for surgery? morbid obesity.What color cartridge was being used? gold.What tissue was device being fired on? stomach.What is the current patient status? good.Surgery has been extended by 20 minutes and other clamp and a thread suture has been used to finish surgery.Hospitalization has been extended and there were 72h of delay to iniate the enteral and normal nutrition.

Event Description

It was reported that during an unknown procedure, the longitudinal gastric stapling procedure did not work.No stapling, only section with an open stomach, the staples was torn.Hospitalization has been extended of seventy-two hours and there was a delay at initiating the enteral and normal nutrition.No information about the patient to date.Unknown how case was completed.

Manufacturer Narrative

(b)(4).Date sent: 06/01/2016.(b)(4).The analysis results showed that an long60a was received in good visual condition and with four ecr60d reloads present.Reloads b, c and d were received fully fired; reload e was received fully fired, with 4 drivers missing and one driver out of position making the reload non-functional.The pan was partially dislodged.The damage to drivers is consistent with clamping the device over a hard object.When this happens there is not enough space for the sled pushing the staple driver up to continue its run due to the obstruction, this is the reason why the drivers get damaged.When the mechanism is forced the sled will deform enough to bypass the drivers in contact with the sled and continue the stroke.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.For further information please refer to the instructions for use.The device was tested for functionality in the articulated position with a test cartridge reload and achieved its complete 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.However, the knife was noted nicked.One possible cause for this type of damage to the knife is when the device is fired over an already existing staple line, hard object or thicker tissue than indicated.Repeatedly firing across existing staple lines can also reduce the ability to cut cleanly.It should be noted that 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.

• 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: 5640233
• MDR Text Key: 44697496
• Report Number: 3005075853-2016-02533
• 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: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Catalogue Number: LONG60A
• Device Lot Number: N90J0K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization