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 Abdominal Pain (1685); Post Operative Wound Infection (2446)

Event Date 01/05/2021

Event Type  Injury  

Event Description

Title: robotic complete mesocolic excision (cme) is a safe and feasible option for right colonic cancers: short and midterm results from a single-centre experience.The aim of this study is to describe the results of a standardised technique for complete mesocolic excision surgery for colon cancer with the use of davinci robotic platform.Between january 2015 and september 2019, 77 patients undergoing standardised robotic complete mesocolic excision technique with superior mesenteric vein first approach were included in the study.There were 34 males and 43 females with a median age of 69 (34¿89) years.During the procedure, common enterotomy (stapler ends) is closed with two-layer vicryl 3/0 stitch (ethicon).The specimen is extracted through suprapubic pfannenstiel incision.A layered closure is performed with pds (ethicon) and monocryl (ethicon) sutures.Complications include small bowel injury (n=1), small bowel obstruction (n=1), wound infection (n=3), ileus (n=3), and abdominal pain (n=1).In conclusion, robotic complete mesocolic excision is feasible, effective and safe.Good oncological results and improved survival are seen in this cohort of patients with a standardised approach to robotic complete mesocolic excision.

Manufacturer Narrative

(b)(4).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.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.Related events captured via / events were submitted via 2210968-2022-03561 and 2210968-2022-03563.Citation: surgical endoscopy (2021) 35:6873¿6881, https://doi.Org/10.1007/s00464-020-08194-z.

• 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
• MDR Report Key: 14349605
• MDR Text Key: 291964648
• Report Number: 2210968-2022-03562
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• 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: 04/28/2022
• 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