MAUDE Adverse Event Report: ETHICON INC. GYNECARE INTERCEED 5INX6IN; BARRIER, ABSORBABLE, ADHESION

Catalog Number 4350XL

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

Patient Problems Adhesion(s) (1695); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

It was reported that a patient underwent a laparoscopic colon resection procedure on an unknown date and an absorbable adhesion barrier was used.The patient was discharged 10 days after surgery, however, one week after the discharge, the patient was readmitted to the hospital because of poor food passage.Then, reoperation was performed due to suspected bowel obstruction.There was a bowel obstruction.It was attached/had adhesions only where the adhesion barrier was used.(the ochre color of the adhesion barrier could be seen around the incision wound.) it seems that probably the adhesion barrier caused some biological reaction and because of that, the intestine stuck together.The patient was already discharged from the hospital and returned to society.The surgeon said, ¿i have had similar experiences with other anti-adhesion materials, but i felt that the anti-adhesion materials may have reacted to the anti-adhesion materials and pulled them in the opposite direction.I think that anti-adhesion material is necessary in open cases, but i feel that it is unnecessary in laparoscopic surgery because the skin incision is small.¿ additional information has been requested.

Manufacturer Narrative

(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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what symptoms did the patient experience following the index surgical procedure? onset date? other relevant patient history/concomitant medications? were pre-existing adhesions noted during the procedure? how were the post-procedural adhesions confirmed? what is the location and severity of the adhesions? please describe any surgical intervention required including the date and results.Was meticulous hemostasis performed prior to use of product? what color was the interceed prior to closure? did the interceed come in contact with heme prior to use? how was the product applied? one layer? wadded? what suture was used to close the incision? was there excessive tissue desiccation (cautery use) at the site of interceed application? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? product lot number? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.

Manufacturer Narrative

(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.Additional information was requested and the following response was received: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedureunk.Date of index surgical procedure?:laparoscopic colorectomy the diagnosis and indication for the index surgical procedure?:unk.Were any concomitant procedures performed?: no.What symptoms did the patient experience following the index surgical procedure?: onset date?: one week after the discharge, the patient was readmitted to the hospital because of poor food passage.Then, reoperation was performed due to suspected bowel obstruction.Other relevant patient history/concomitant medications?:no were pre-existing adhesions noted during the procedure?:not reported how were the post-procedural adhesions confirmed?:with reoperation what is the location and severity of the adhesions?:only the part of interceed used was adhered.Please describe any surgical intervention required including the date and results.The patient was discharged at 10 days after initial surgery, but one week after the discharge, the patient was readmitted to the hospital because of poor food passage.Then, reoperation was performed due to suspected bowel obstruction.Was meticulous hemostasis performed prior to use of product?:unk.What color was the interceed prior to closure?:unk.Did the interceed come in contact with heme prior to use?:yes how was the product applied?: one layer?: wadded?:unk.What suture was used to close the incision?:unk.Was there excessive tissue desiccation (cautery use) at the site of interceed application?:no.What is the physician¿s opinion as to the etiology of or contributing factors to this event?:since the area where interceed was used was clearly adhered, i cannot help but suspect that interceed caused some kind of biological reaction that caused the intestines to adhere.What is the patient's current status?: the patient was already discharged from the hospital and returned to society.Product lot number?:unk.

• Brand Name: GYNECARE INTERCEED 5INX6IN
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18372036
• MDR Text Key: 331094605
• Report Number: 2210968-2023-10015
• Device Sequence Number: 1
• Product Code: MCN
• UDI-Device Identifier: 10705031147843
• UDI-Public: 10705031147843
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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
• Device Catalogue Number: 4350XL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 12/28/2023
• Supplement Dates FDA Received: 01/16/2024
• 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