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 Hemorrhage/Bleeding (1888); Necrosis (1971); Unspecified Tissue Injury (4559)

Event Date 06/19/2023

Event Type  Injury  

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.Related events captured via 2210968-2024-02161 and 2210968-2024-02162.Citation: journal of surgical oncology.Doi:10.1002/jso.27382.

Event Description

Title - closure of pelvic peritoneum with bladder peritoneum flap reconstruction after laparoscopic extralevator abdominoperineal excision: a prospective stage ii study the aim of the present study was to report the development and preliminary outcomes of blaper.(bladder peritoneum flap reconstruction).From (b)(6) 2017 to (b)(6) 2022, 139 low rectal cancer patients underwent l-elape at our center, among them, 27 patients received blaper.The characteristic of the included patients has been listed in table 2.The median age of the enrolled patients was 57 years, with a median follow-up time of 19 months.One patient failed to complete blaper due to the tear of the flap.A total of 26 patients were included in the current analysis.The procedure of l-elape followed the principle of total mesorectal excision and the principle of perineal procedure of elape.During the procedure, the harvested bladder peritoneum flap (¿u¿ flap) is turned over to cover the entrance of the pelvic cavity and sutured to the brim of the pelvis with a running suture (prolene).In the ideal stage ii, one of the tasks is to develop the surgical procedure through the exploration of a small number of cases.To determine the blood supply of the bladder peritoneal flap, 2 ml indocyanine green (icg) fluorescence (2 mg/ml) was injected intravenously after the harvest of the flap.To minimize potential intestinal adhesions to the rough surface of the overturned flap, a 10 × 10 cm absorbable adhesion barrier (interceed; ethicon inc.) was used to cover the surface of the bladder and the overturned bladder peritoneal flap.Reported complication: bleeding (n-?).Flap necrosis (n-?).Flap tear (n-?).Bladder injury (n-?).Peritoneum tear (n-1).Conclusions: blaper is safe and may prevent the small bowel from descending into the retrourogenital space and subsequently developing ph and sbo without increasing the intraoperative and postoperative complications.Blaper may serve as an option when the primary suture of the pelvic peritoneum is not feasible.

• 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.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18812511
• MDR Text Key: 336620865
• Report Number: 2210968-2024-02162
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Not provided
• Initial Date FDA Received: 02/29/2024
• 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): Other