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 Problem Obstruction/Occlusion (2422)

Event Date 03/22/2023

Event Type  Injury  

Event Description

Title: benefits of laparoscopic liver resection in elderly patients this study investigated the short-term outcomes of laparoscopic liver resection in elderly patients as compared to nonelderly patients.Between april 2016 and november 2021, 297 patients who underwent laparoscopic liver resection were reviewed and included in the study.Among the 297 patients, 181 were < 75 years of age (non-elderly group) and 116 were = 75 years age (elderly group).The entire study of 297 patients consisted of 215 men and 82 women with a median age of 72 years (range 19¿91 years).All patients underwent parenchymal-sparing anatomic resection for liver malignancies.Adhesion barriers, including a competitor spray-type barrier (manufacturer: terumo) or sheet-type barriers, interceed (ethicon) or a competitor (manufacturer: baxter), were applied routinely around the hepatoduodenal ligament, hepatic hilum, remnant liver, diaphragm, stomach, and area under each trocar in most cases of laparoscopic liver resection.Reported complications included adhesive intestinal obstruction (n=?).In conclusion, laparoscopic liver resection in elderly patients may provide comparable short-term outcomes to those in non-elderly patients.

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.The following information was requested, but unavailable: 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: surgical endoscopy (2023) 37:5205¿5214; https://doi.Org/10.1007/s00464-023-09986-9.

• 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: 17772736
• MDR Text Key: 323712936
• Report Number: 2210968-2023-06843
• 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

• Date FDA Received: 09/19/2023
• 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: 09/01/2023
• 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