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 Adhesion(s) (1695); Unspecified Infection (1930); Obstruction/Occlusion (2422)

Event Date 03/23/2023

Event Type  Injury  

Event Description

Title: risk factors for small-bowel obstruction after colectomy for colorectal cancer: a retrospective study.This study aimed to investigate the risk factors for postoperative small-bowel obstruction after colectomy for colorectal cancer.Between january 1, 2009 and december 31, 2018, 1646 patients who underwent colectomy for colorectal cancer were included in the study.Patients were divided into a small bowel obstruction group and a non- small bowel obstruction group.In the small bowel obstruction group, there were 67 patients consisting of 42 males and 25 females with a mean age of 66 years (range 61-74).In the non-small bowel obstruction group, there were 1579 patients consisting of 894 males and 685 females with a mean age of 68 years (range, 60-75).In this study, the proportion of barrier-type adhesion prevention material used was 94.1% for a competitor hyaluronate carboxymethyl cellulose (seprafilm, manufacturer: baxter), 2.1% for oxidized regenerated cellulose (interceed, ethicon), and 3.8% for a competitor dextrin hydrogel (adspray, manufacturer: terumo).The sheet-type barriers (interceed or seprafilm) were placed only below the median wound while the spray type adhesion prevention material (adspray, manufacturer: terumo) was used for the entire adhesion-peeling part.Reported complications included superficial/deep surgical site infection (n=?), adhesion (n=?), and small bowel obstruction (n=?).In conclusion, tumor localization in the rectum is associated with several problems, including a wide resection area, prolonged operative duration, and high risk of anastomotic leakage, which may increase the risk of small bowel obstruction.Laparoscopic surgery and adhesion prevention material did not demonstrate a clear preventive effect against small bowel obstruction.

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.An attempt has been 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.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: surgery today; https://doi.Org/10.1007/s00595-023-02674-0.

• Brand Name: INTERCEED (TC7) UNKNOWN PRODUCT
• 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; 982 road 183 km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17772876
• MDR Text Key: 323715774
• Report Number: 2210968-2023-06846
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/19/2023
• 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