MAUDE Adverse Event Report: ETHICON INC. NUROLON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Post Operative Wound Infection (2446); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Citation: br.J.Surg.1985, vol.72, august, 60s605.(b)(4).

Event Description

It was reported via journal article, title: "staples or sutures for low colorectal anastomoses: a prospective randomized trial," authtors: f.P.Mcginn, p.C.Gartell, p.C.Clifford and f.J.Brunton.Citation: br.J.Surg.1985, vol.72, august, 60s605.The aim of this prospective, randomized trial was to compare results for low colorectal anastomoses performed with either the staple gun or sutures.Over a five-year period, from september 1979 to 1984, 118 consecutive patients undergoing low colorectal anastomoses were randomized in theatre, after assessing operability, into one of two methods of anastomosis: staples delivered by gun inserted through the anus; or sutures by hand via the abdomen.Patient demographics included: suture group: 29 males, 31 females ages 37 to 85.Staple group: 31 males, 27 females ages 45 to 84.During the procedure, with stapled anastomoses, proximal and distal purse-string sutures were inserted using an ¿over and over¿ technique with 2/0 prolene before insertion of an appropriate-sized circular staple gun (either e.E.A.Autosuture or i.L.S.Proximate).Sutured anastomoses were carried out using single layer, interrupted, extramucosal 3/0 braided polyamide (nurolon, ethicon, ltd).Anastomotic integrity was checked by instilling 50-100 ml air into the rectum after pouring warm saline into the pelvis.Any leak was over sewn with 3/0 nurolon sutures until the anastomosis was airtight.There were 7 clinical leaks in the remaining 54 stapled patients (12 per cent), and 2 clinical leaks in the 60 sutured patients (3 per cent).Radiological leaks were present in another 14 stapled anastomoses but in only 4 sutured anastomoses (7 per cent).Other complications included: wound infection; suture group- (n=3), staple group- (n=5) and rectal hemorrhage; staple group- (n=1).Only 4 patients (7 per cent) with sutured anastomosis underwent colostomy.Of the stapled patients 11 (19 per cent) were given colostomies, but it must be pointed out that 8 were made in the first 20 stapled cases, and 1 when the gun failed.The event of rectal hemorrhage was managed by 10-unit blood transfusion and a rectal pack.In conclusion, the authors could find no significant difference in the postoperative stay for our patients, but as a tenfold increase in cost occurred with a stapled anastomosis, which was associated with increased morbidity in our hands, we intend to abandon the method for our patients.

• Brand Name: NUROLON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NON ABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8041263
• MDR Text Key: 126226434
• Report Number: 2210968-2018-76961
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: E.E.A. AUTOSUTURE OR I.L.S. PROXIMATE
• Patient Outcome(s): Required Intervention