MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH STEALTH CIR STAPLER; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number ILSX

Device Problem Failure to Form Staple (2579)

Patient Problems Unspecified Infection (1930); Ulcer (2274)

Event Type  Injury  

Manufacturer Narrative

(b)(4).As a lot/batch was not provided, a device history could not be performed.

Event Description

It was reported in a journal article: comparison of hand-sewn, linear-stapled, and circular-stapled gastrojejunostomy in laparoscopic roux-en-y gastric bypass authors: frank p.Bendewald, jennifer n.Choi, lorie s.Blythe, don j.Selzer, john h.Ditslear, samer g.Mattar.Citation: obes surg 2011;21:1671-1675.Doi 10.1007/s11695-011-0470-6.In this article, the authors present their experience with 3 gastrojejunostomy techniques and attempt to determine which technique is associated with the fewest anastomotic complications within the first 60 postoperative days.The 835 patients undergoing bariatric surgery at a single academic institution from november 2004 through december 2009 was reviewed.The type of gastrojejunostomy anastomosis (gja) performed [hand-sewn (hsa), linear-stapled lsa, or 25-mm circular stapled (csa)] was recorded and postoperative gastrojejunostomy leak, stricture, and marginal ulcer were identified.In the hsa technique (n=181; 157 female, 24 male; mean age 45.7 years; mean bmi 48.6 kg/m2), continuous 2-0 polydioxanone suture is used to complete the 2-layer anastomosis.In the csa technique (n=140; 118 female; 22 male; mean age 45.8 years; mean bmi 47.8 years), an 25-mm ils circular stapler was used.Complications in the lsa and csa group include: leak (lsa, n=5), stricture (lsa, n=31; csa, n=6), marginal ulcer (lsa, n=41; csa, n=5), trocar site infection rate (lsa, 2.5%; csa 4.3%).

• Brand Name: ENDOPATH STEALTH CIR STAPLER
• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 6994935
• MDR Text Key: 90835897
• Report Number: 3005075853-2017-05828
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2017

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: ILSX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 11/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention