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 Therapeutic Response, Decreased (2271); 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: ann r coll surg engl.1999; 81: 105-108.(b)(4).

Event Description

It was reported via journal article: "title : controlled intraoperative water testing of left-sided colorectal anastomoses: are ileostomies avoidable?".Author: j m d wheeler frcs, j m gilbert ms frcs.Citation: ann r coll surg engl.1999; 81: 105-108.Anastomotic leakage is a major problem in colorectal surgery, and previous studies have suggested that intraoperative identification of leaks allows repair at the time of surgery.This study examined whether testing allowed a defunctioning ileostomy to be safely omitted.A series of 102 consecutive patients (52 male and 50 female patients; age range: 16 to 89 years old) underwent left-sided colorectal anastomosis and were studied prospectively.During the anterior resection procedure, the splenic flexure was mobilized and an end-to-end anastomosis was performed with randomization to either staples or sutures.There were 50 anastomoses stapled and 52 sutured (handsewn) with single layer nurolon 2-0 interrupted seromuscular inverting sutures (ethicon).In the handsewn group, reported complications included patient 1, an (b)(6) male patient with clinical leak, rectal bleeding, and pelvic abscess which required transverse colostomy, and drainage of pelvic abscess; patient 3, a (b)(6) female patient with clinical leak which was treated conservatively; patient 5, an (b)(6) male patient with clinical leak which was treated conservatively; patient 7, a (b)(6) male patient with late clinical leak which required loop ileostomy; failure of initial water test (n-10) which required strengthening of the anastomosis; failure of the second water test (n-3) which required loop ileostomy in 2 patients and tube caecostomy in 1 patient; and leak on water-soluble contrast enema (n-8) which were treated conservatively.In conclusion, controlled water testing of left-sided colorectal anastomoses at the time of surgery allowed incomplete anastomoses to be corrected intraoperatively.A defunctioning ileostomy was avoided in 98% of patients, and in 96% of low anastomoses.Intraoperative testing is helpful in anterior resection, but does not guarantee that an intact anastomosis will remain intact post-operatively.

• 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: 8020749
• MDR Text Key: 125594085
• Report Number: 2210968-2018-76834
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• 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: 10/11/2018
• 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
• Patient Outcome(s): Required Intervention