MAUDE Adverse Event Report: ETHICON INC. NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

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

Patient Problems Impaired Healing (2378); Post Operative Wound Infection (2446)

Event Date 12/19/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.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.Component code: (b)(4): device not returned the single complaint was reported with multiple events.There are no additional details regarding the additional events.Events reported via 2210968-2022-05601, and 2210968-2022-05603.Citation cite: korean j gastroenterol 2022;79:109-117.Orcid: https://orcid.Org/0000-0002-7793-0148.

Event Description

Title: comparison between wound closure methods in the reversal of diverting ileostomy.The objective of this study was to determine the more appropriate wound-closure method by comparing the effectiveness of two methods in a group of patients who underwent ileostomy repair.The study conducted after obtaining the approval of the institutional review board (irb) included 58 patients =19 years of age who underwent ileostomy at the department of surgery at the presbyterian medical center.This was a retrospective, single-center trial.Patients who underwent ileostomy closure between january 2011 and september 2017 were assigned to the primary wound-closure (pc, n=25) group and the purse-string wound-closure (psc, n=33) group.Lateral-lateral anastomosis was performed by automatic stapling, while the fascia layer was approximated by a continuous suture using looped 0/0 polydioxanone.Subsequently, the subcutaneous layer was approximated using 2/0 vicryl sutures in the pc group, followed by skin approximation by interrupted suturing with four or five stitches using 2 or 3/0 nylon.In the psc group, the subcutaneous layer was left unapproximated or only one or two sutures were used, after which the dermal layer was approximated by continuous suturing using 0/0 nylon.Reported complications included surgical site infection (n=11), delay wound healing (n=18), in conclusion psc has a lower surgical site infection rate and the wound-healing delay was not very different from that of pc.Therefore, if patients are at risk of wound infection, such as in severe wound contamination, long operating time, and immunocompromised conditions, we should consider psc as a wound closure method of choice.

• Brand Name: NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15044079
• MDR Text Key: 296137034
• Report Number: 2210968-2022-05602
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2022

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2022
• Initial Date FDA Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention