MAUDE Adverse Event Report: ETHICON INC. PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Wound Dehiscence (1154); Sepsis (2067)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to fda: 9/19/2022.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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: international journal of surgery 83 (2020) 102¿106, https://doi.Org/10.1016/j.Ijsu.2020.08.043.

Event Description

Title: impact of choledochotomy techniques during laparoscopic cbd exploration on short- and long-term clinical outcomes: time to change concepts (a retrospective cohort study) this study aimed to retrospectively analyze and compare the impact of choledochotomy techniques during lcbde among patients with choledocholithiasis during the early and late postoperative periods.From (b)(6) 2014 to (b)(6) 2018, 85 patients with choledocholithiasis were included in the study.These patients were treated by laparoscopic common bile duct exploration using various choledochotomy techniques, including an unknown manufacturer scalpel or scissor (28 patients) in group i, an unknown manufacture diathermy hook (35 patients) in group ii, or an ultrasonic device (22 patients) in group iii.Group i consisted of 17 females and 11 males with a mean age of 44.79 ± 10.77 years and underwent choledochotomy procedure using an unknown manufacturer scalpel/scissor.Group ii consisted of 19 females and 16 males with a mean age of 48.23 ± 12.30 years and underwent choledochotomy procedure using an unknown manufacturer diathermy hook.Group iii consisted of 16 females and 6 males with a mean age of 46.82 ± 6.86 years and these patients underwent choledochotomy using ultracision harmonic scalpel (ethicon endo-surgery).Stone extraction was done either through choledochoscopic removal or by direct methods, including common bile duct milking and stone grasping, dormie basket, balloon extraction irrigation/suction, or combined technique.The closure was performed using a pds 4/0 suture (ethicon) the reported complications included wound sepsis (n=7) and wound dehiscence (n=2) in conclusion, the long-lasting concepts of avoidance of using energy machines such as diathermy and ultrasonic devices with biliary structures should be changed.However, a statistical type i error cannot be excluded because of the small sample size.Therefore, further analysis of prospective randomized studies with a larger number of participants is strongly recommended.

Manufacturer Narrative

(b)(4).Date sent to the fda: 10/18/2022.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.Additional information was requested, and the following was obtained: does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.No.None believed that there was a deficiency in the ethicon devices.

• Brand Name: PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, 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: 15446424
• MDR Text Key: 300154215
• Report Number: 2210968-2022-07674
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: N18331
• 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,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2022
• 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