MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. PROXIMATE*RL TITAN HEAVY WIRE; STAPLE, IMPLANTABLE

Catalog Number	TLH60
Health Effect - Clinical Codes	Fistula (1862); Urinary Retention (2119); Blood Loss (2597); No Code Available (3191)
Date of Event	05/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
Event or Problem Description
It was reported via literature entitled: side-to-end vs.Straight stapled colorectal anastomosis after low anterior resection: results of randomized clinical trial author: e.G.Rybakov, d.Yu pikunov, o.Yu fomenko, s.V.Chernyshov, yu a.Shelygin citation: int j colorectal dis (2016) 31:1419¿1426; doi 10.1007/s00384-016-2608-4, published online: 30 may 2016.The aim of this study is to compare surgical, functional, physiologic outcomes and qol after low anterior resection (lar) with and side-to-end or straight colorectal anastomosis.Between 2012 and 2015, there were 81 patients included and were randomized into two groups: side-to-end, 13 males, 28 females, age range: 51 to 65 years, bmi= 25-29 and straight, 20 males, 20 females, age range: 58 to 69 years, bmi= 2 7-30.During the procedure, rectal dissection was performed in mesorectal plane with total mesorectal excision (tme).During the procedure, the contour® curved cutter stapler (ethicon endo-surgery, inc.) was applied at the site of the anorectal junction to close the rectal stump.A double-stapling technique was used both for straight or side-to-end colorectal anastomosis.A premium plus ceea¿ 31 stapler (covidien, usa) was used for the creation of the supra-anal colorectal anastomosis.In the case of a straight anastomosis, the anvil of the circular stapler was inserted into the colonic lumen and fixed by a purse-string suture.For a side-to-end anastomosis, the anvil of the circular stapler was inserted into the colon lumen and the bowel wall was stubbed at the site of free colonic taenia by the shaft of the anvil 7¿8 cm proximal to the end of the divided bowel.Then, the blind end of the bowel was closed using a proximate linear stapler tlh-60 (ethicon endo-surgery, llc, usa).In all cases, the colorectal anastomosis was defunctioned by transverso- or ileostomy.The only case of grade iiib complication according to the clavien-dindo classification developed in the side-to-end group.There was 1 patient had profuse bleeding from the mesentery of the colon used for anastomosis required reoperation in the side-to-end group and 1 case of mucocutaneous stoma from the straight group.Four male patients (two in each group) had suprapubic cystostomy for prolonged urinary retention (grade iiia complication).Two anastomotic leakages (5.0 %) developed after straight anastomosis.A low recto-vaginal fistula developed in one patient (2.4 %) after side-to-end anastomosis.All leaks were diagnosed between five and seven postoperative days and resulted in moderate clinical symptoms requiring the administration of antibiotics and transanal lavage (anastomotic leakage grade b).At 6 months after surgery, all anastomoses as well as the recto-vaginal fistula healed spontaneously and there was no extravasation on contrast enema examination.The defunctioning stoma was closed in all cases.In conclusion, better functional outcomes and qol were observed in a short period after stoma closure, but at 6 months of follow-up, the only benefit of side-to-end anastomosis was a lower number of bowel movements.

• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7742246
• Report Number: 3005075853-2018-11802
• Device Sequence Number: 1315506
• Product Code: GDW
• UDI-Device Identifier: 20705036013232
• UDI-Public: 20705036013232
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K020779
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/06/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: TLH60
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 08/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention