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

Catalog Number INTERCEEDUNK

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

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

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.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (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 product (interceed) involved? please provide the underlying cause of sudden death in this study? was this case attributed to the use of interceed? citation: surgery today (2019).Doi: https://doi.Org/10.1007/s00595-019-01816-7.(b)(4).

Event Description

It was reported in a journal article with title : a prospective multi-center registry concerning the clinical performance of laparoscopic colorectal surgery using an absorbable adhesion barrier ( interceed®) made of oxidized regenerated cellulose the aim of this prospective, multi-center registry was to evaluate the safety and clinical performance of the synthetic absorbable adhesive barrier interceed® in laparoscopic colorectal surgery.This prospective, multi-center, single-arm registry study involves 200 patients (105 male and 95 female; mean age: 68.6 ± 10.8; age range: 29-92 years; mean bmi: 22.46 ± 3.43 kg/m2; bmi range: 14.8 to 34.2 kg/m2) who underwent laparoscopic colorectal surgery using interceed (ethicon) between mar 2012 and mar 2015.After complete hemostasis and liquids were completely removed from within the abdomen, the interceed (ethicon) was cut to an appropriate size (approximately 3¿5 mm larger than the site requiring adhesion prevention, such as an umbilical small incision and exfoliated surface).Interceed® was placed over or between the exposed surfaces to prevent the exposed surface from adhering to the adjacent tissue.The interceed® was inserted via the umbilical small incisional when applied under an umbilical small incision and via the trocar when applied to the pelvic floor.Care was taken not to wrap the anastomotic site with interceed®.Securing with sutures was deemed unnecessary.Immediately before abdominal closure, a single layer of interceed® was applied under dry conditions.If the interceed® sheet was stained black, sufficient prevention of adhesion could not be expected, so the sheet was promptly removed, and a new one was applied after hemostasis had been achieved again.If a single sheet was insufficient to cover the entire target site, additional sheets were used, with overlap by 3¿5 mm to ensure complete coverage of the target site.The sheets were moisturized with up to 2 ml of physiological saline per 3 × 4 in.(7.6 × 10.2 cm) to ensure complete attachment to the tissue.Reported complication included postoperative adhesion intestinal obstruction (n-2).In conclusion, using interceed® in laparoscopic colorectal surgery is safe and may be useful for preventing postoperative adhesive small intestinal obstruction.

• 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 INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9273491
• MDR Text Key: 166156888
• Report Number: 2210968-2019-89481
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: INTERCEEDUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• 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