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 Wound Dehiscence (1154); Abortion (1688); Headache (1880); Hemorrhage/Bleeding (1888); Impaired Healing (2378); Numbness (2415); Fluid Discharge (2686); Syncope/Fainting (4411); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/17/2021

Event Type  Injury  

Event Description

Title: operative and obstetric outcomes after single-port laparoscopic myomectomy: a retrospective single-center analysis of 504 cases.The objective of this study is to analyze the obstetric and operative outcomes of 504 cases of single-port laparoscopic myomectomy (splm).It is a single-center retrospective study with a total of 502 patients (504 splm procedures) who underwent splm for symptom relief or growing myomas between october 2009 and april 2020.The mean age of the patients was 40.6 + 6.6 years.The patients had had an average of 2.3 + 2.2 myomas removed; the largest myoma size was 6.8 + 2.4 cm.A myometrial incision was then made vertically, using a monopolar or ultrasonic device (harmonic scalpel; ethicon endo-surgery, cincinnati, oh), until the myoma surface was visible.After removing the myoma(s), the myometrium was repaired with interrupted intracorporeal absorbable sutures (vicryl; ethicon endo-surgery, cincinnati, oh).Enucleated myomas were extracted using an electromechanical morcellator (x-tract; ethicon endo-surgery, cincinnati,oh).After irrigation, an adhesion barrier (interceed; ethicon endo-surgery, cincinnati, oh) was applied at the myomectomy site.The fascia and peritoneum were sutured using 2-0 vicryl sutures (ethicon endo-surgery, cincinnati, oh) and the skin was closed using 4-0 vicryl sutures (ethicon endo-surgery, cincinnati, oh).Reported complications included intraoperative complication loss of blood and bowel injury (n=4).Postoperative complications: blood loss (n=16), wound complication (serous discharge, minor dehiscence, maladaptive wound healing) (n=15) , headache, thigh numbness, and syncope (n=6), recurrence (n=148).Ten patients experienced obstetric complications, including uterine atony, placenta previa, preterm labor, second-trimester bleeding.Aborted pregnancies (n=2).In conclusion we observed in this study that splm was feasible and safe for treating symptomatic or growing myomas and that it was associated with satisfactory obstetric outcomes.Therefore, splm is a safe and effective option for women who require surgical treatment for myomas but wish to preserve their fertility.

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Attempts are being 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? 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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2022-05105, 2210968-2022-05106 and 2210968-2022-05107.Citation: https://doi.Org/10.1016/j.Jmig.2021.06.011.

• 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: 14918760
• MDR Text Key: 295272661
• Report Number: 2210968-2022-05106
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 07/05/2022

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: 06/21/2022
• Initial Date FDA Received: 07/05/2022
• 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