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

Catalog Number ECXXX

Device Problem Defective Component (2292)

Patient Problems Adhesion(s) (1695); Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Batch # unk.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.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.Does the surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.

Event Description

It was reported in journal article title: a stepwise approach in learning surgical residents a roux-en-y gastric bypass.Authors: a.B.Walinga, s.R.Van mil, l.U.Biter, m.Dunkelgrün, g.H.E.J.Vijgen.Citation: obesity surgery.2019; 29: 414¿419.Doi: https://doi.Org/10.1007/s11695-018-3533-0.This study describes a stepwise training program to teach a laparoscopic roux-en-y gastric bypass (lrygb).Results of a resident are compared to experienced bariatric surgeons (ebs).Between january 2016 and september 2016, the resident performed 29 consecutive bariatric procedures (age: 44 ± 9 years; 25 female and 4 male patients; bmi: 42.19 ± 4.22) and 30 consecutive patients for the ebs group (age: 40 ± 12 years; 25 female and 5 male patients; bmi: 39.54 ± 2.60).During the surgical procedure in both groups, the lrygb is created with a small gastric pouch of 15 cc, which is anastomosed over 3 cm with a linear stapler to a 150-cm alimentary limb.The gastrojejunostomy is created with a linear technique using an echelon flex 60 powered stapler with a blue cartridge (ethicon).After stapling, the stapler defect is closed with a double layer stratafix suture (ethicon), after which a side-to-side jejunojejunostomy is created with a 60-cm biliopancreatic limb by using the same echelon flex 60 (ethicon) and after stapling the defect is closed with suture.In the ebs group, reported complications included abdominal hemorrhage (n-2) and obstruction in the small bowel caused by adhesion (n-2).In the resident group, reported complications included bleeding (n-2) and suture leakage (n-1).In conclusion, the stepwise training program results in a fast and efficient way to approach the learning curve of the experienced bariatric surgeons.Within this program, the total time of the operation will be kept low and the operation will be less intensive for the patients.The results of this study could act as a guideline for the development of such a training program.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent: 6/25/2019.Corrected data: mdr decision: not reportable.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.Reviewed additional information added 6/18/19.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.Additional information requested and received: does the author/surgeon believe that the ethicon devices mentioned in this article caused/contributed to the reported events in the article? if yes, please explain.No the surgeons and authors don't believe that the ethicon devices caused the events.

• Brand Name: ECHELON ENDOPATH STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8699835
• MDR Text Key: 148062123
• Report Number: 3005075853-2019-19743
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• PMA/PMN Number: K051002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/14/2019
• Supplement Dates Manufacturer Received: 06/18/2019
• Supplement Dates FDA Received: 06/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention