MAUDE Adverse Event Report: ETHICON INC. INTERCEED (TC7) UNKNOWN PRODUCT; BARRIER, ABSORBABLE, ADHESION

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

Patient Problems Abscess (1690); Adhesion(s) (1695); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Attempts are being made to clarify 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 ethicon products (interceed) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products (interceed) used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? the single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: world j surg; https://doi.Org/10.1007/s00268-020-05743-4.

Event Description

Title: safety of use of a sheet-type adhesion barrier (interceed) during liver surgery.This prospective study aimed to investigate the safety of the use of interceed during liver surgery through an evaluation of the incidence and/or severity of liver-associated postoperative morbidities.Between september 2016 and march 2020, a total of 101 patients (n=80 males, median age: 71 years, age range: 37-85 years, median bmi: 22.2, bmi range: 14.5-33.8) who received interceed as an adhesion barrier and 134 patients who did not receive any adhesion barrier during liver surgery were compared.The interceed (ethicon) was placed around the liver, including hepatoduodenal ligament, liver surface, and dissected areas.Complaints included blood loss (range of 0-2258) (n=?), any postoperative morbidities (n=17), bile leak (n=4), abscess (n=2), refractory ascites (n=1), and mild adhesion in patients who had relaparotomy (n=6).In conclusion, interceed may not significantly increase a risk of liver resection in both the global and major postoperative morbidities.

• Brand Name: INTERCEED (TC7) UNKNOWN PRODUCT
• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON SARL-NEUCHATEL; puits-godet 20; neuchatel ; SZ
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10726334
• MDR Text Key: 212791124
• Report Number: 2210968-2020-08283
• Device Sequence Number: 1
• Product Code: MCN
• 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,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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: 09/24/2020
• 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