MAUDE Adverse Event Report: ETHICON INC. VERSAPOINT ELECTRODE UNKNOWN PRODUCT; HYSTEROSCOPE (AND ACCESSORIES)

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

Patient Problems Spontaneous Abortion (4514); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2019

Event Type  Injury  

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.(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.Citation cite: journal of international medical research 48(3) 1¿9 doi: 10.1177/0300060519893836.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.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 (versapoint electrode) 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 involved? patient demographics?.

Event Description

It was reported in a journal article with title: reproductive outcome of a complete septate uterus after hysteroscopic metroplasty.This study aimed to evaluate the reproductive outcomes of patients who underwent hysteroscopic metroplasty for correction of a complete septate uterus.The study population comprised 92 women with complete septate uteri.Hysteroscopic metroplasty and laparoscopy were performed simultaneously in these patients.The postoperative reproductive outcome of each patient was evaluated.The hysteroscopic procedure was performed during the early follicular phase of the menstrual cycle.All patients received antibiotics for prophylaxis to prevent secondary pelvic inflammatory disease.All procedures were performed under general anesthesia and in sterile conditions.Surgery was performed through a 6.5-mm operating hysteroscope with a bipolar versapoint electro-surgical system (gynecare, division of ethicon, inc., menlo park, ca, usa).Distention and irrigation were performed using normal saline solution at a pressure of 90 to 110 mm hg.The cutting current was set at 80 to 100 w.After visualizing both tubal ostia,an incision of the septa was started from the lower margin and continued upward with the horizontal section until the hysteroscope could be moved freely from one tubal ostium to the other without obstruction and until both tubal ostia could be visualized.All surgical procedures took 10 to 20 minutes.Reported complications included miscarriage (n=6), ectopic pregnancy (n=2).In conclusion hysteroscopic uterine metroplasty may improve the reproductive performance of a septate uterus.Resection of the cervical septum may increase the probability of a live-birth pregnancy for patients with a cervical septum, and this procedure could be recommended for cases of a complete uterine septum.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/09/2021.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, 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: 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 (versapoint electrode) 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 involved? patient demographics?.

• Brand Name: VERSAPOINT ELECTRODE UNKNOWN PRODUCT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; 7 fortran road; cardiff CF3 0 LT; UK CF3 0LT
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12770103
• MDR Text Key: 281655417
• Report Number: 2210968-2021-10990
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K040302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2021
• 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 Sex: Female