MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

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

Patient Problems Hemorrhage/Bleeding (1888); Urinary Retention (2119); Obstruction/Occlusion (2422); Insufficient Information (4580)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.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? which specific ethicon products have been used during the procedures (product code, lot number)? 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.Patient demographics? 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.Device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: journal of liaoning university of traditional chinese medicine vol.20 no.5 may, 2018 doi: 10.13194/j.Issn.1673-842x.2018.05.027 please see article attached.

Event Description

Title: clinical study on the treatment of mixed hemorrhoids by using the dam-board to modified procedure for prolapse and hemorrhoid this study aims to compare study of the clinical efficacy and complications, and postoperative recurrence rate between modified procedure for prolapse and hemorrhoid (pph) and conventional procedure for prolapse and hemorrhoid (pph).From february 2016 to february 2017 , 80 cases/patients underwent surgery in the department of anorectal surgery of jiangsu provincial hospital of traditional chinese medicine.A total of 80 cases were included.According to the principle of random allocation, the patients were divided into prolapse and hemorrhoid (pph) modified prolapse and hemorrhoid (pph) group (n = 40).The mean age of the prolapse and hemorrhoid (pph) group was (48.7 ± 10.3) years, with 17 males and 23 females.Modified prolapse and hemorrhoid (pph) the mean age of the groups (fig.49.1 ± 10.7) years, 19 males and 21 females.All patients received combined spinal-epidural anesthesia, and disposable hemorrhoidopexy stapler (including auxiliary parts: anal dilator, suture hook, suture instrument, etc., johnson & johnson, usa) was used.During surgery, the anorectal suture instrument to 3 ~ 4 cm was introduced above the dentate line according to the degree of prolapse perform incomplete purse-string suture, and the specific method is as follows: 2-0 ethicon absorbable sutures.At 1:00 (one side of the baffle), the needle was inserted to make purse-string suture, the needle insertion point was close to the previous needle withdrawal point, and the suture depth was strictly grasped as the submucosa, until the last needle was inserted at 11:00 (the other side of the baffle), about 2 cm of mucosa on the anterior side was not sutured into the purse-string, showing "c" the grapheme open-loop , the anal endoscopic stapler was removed, the circular hemorrhoidal stapler (hcss33) was unscrewed to the maximum position, and paraffin oil was applied to its head to remove the hcs33 it is placed in the anus and its head is directed deep above the purse-string and then tightened to tie the purse-string knot (; 7) with the help of the suture carrier (st100), pull out the tail end of the suture from the side hole of hcs33 and tie the knot for fixation.In this process, the center rod of the stapler shall keep no movement in front and back as far as possible, tighten the stapler until the mark enters the green area.For procedure for prolapse and hemorrhoid (pph) group , a circular anal dilator (cad33) internal plug coated with paraffin oil was introduced into the anus and expanded for 3 min to remove the internal plug and fix the anal dilator.Use 2-0 absorbable suture, make clockwise purse-string suture for 1 week at the position 3 ~ 4 cm away from dentate line, with about 5 or 6 stitches.The rest were the same as the modified procedure for prolapse and hemorrhoid (pph) group.Take note that for female patients, the anterior baffle is located in the rectovaginal septum, the effective purse-string suture is too deep, and the vaginal wall is pulled into the nail hamster, which fundamentally eliminates the possibility of rectovaginal fistula.The postoperative follow-up period was 3 months.Reported complications included: (n=3) urinary retention 2nd degree, poor urination, but no medication, one in the modified procedure for prolapse and hemorrhoid (pph) group and 2 procedure for prolapse and hemorrhoid (pph) group.(n=3) urinary retention 3rd degree, urination after intramuscular injection of neostigmine , one in the modified procedure for prolapse and hemorrhoid (pph) group and one in the procedure for prolapse and hemorrhoid (pph) group.(n=1) urinary retention 4th degree,ineffective use of neostigmine, requiring catheterization , in the procedure for prolapse and hemorrhoid (pph) group.(n=1) post procedural hemorrhage in the procedure for prolapse and hemorrhoid (pph) group.(n=3) anal stenosis in the procedure for prolapse and hemorrhoid (pph) group.(n=4) tenesmus.One in the modified procedure for prolapse and hemorrhoid (pph) group and 3 procedure for prolapse and hemorrhoid (pph) group.It was concluded , that the modified procedure for prolapse and hemorrhoid (pph) with baffle plate can treat mixed hemorrhoids, and has the characteristics of less operative complications and lower recurrence rate than procedure for prolapse and hemorrhoid (pph).

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, ABSORBABLE
• 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: 15798076
• MDR Text Key: 303705595
• Report Number: 2210968-2022-09447
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• 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: 11/07/2022
• 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