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

Catalog Number VERSAUNK

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

Patient Problems Uterine Perforation (2121); Blood Loss (2597)

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 (versapoint) 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 (versapoint) involved? patient demographics.Citation: journal of minimally invasive gynecology (2016) 23, 78¿83 / http://dx.Doi.Org/10.1016/j.Jmig.2015.08.882.(b)(4).

Event Description

Title: assessment of abdominal ultrasound guidance in hysteroscopic metroplasty the purpose of this observational retrospective study was to compare the rates of re-intervention, and immediate and later complications associated with abdominal ultrasound-guided versus unguided hysteroscopic metroplasty.Between jun 2009 and oct 2013, a total of 108 female patients with a uterine septum who underwent hysteroscopic metroplasty were included in the study.The patients were categorized into two groups: having abdominal ultrasound-guided metroplasty (n=46, median age 31 years (range 21¿42 years)) or unguided metroplasty (n=62, median age 31 years (range 21¿45 years)).Resection of the uterine septum was performed with an operative resectoscope fitted with a bipolar electrode with a straight loop gynecare versapoint 5fr, optical lens 2.9 mm (ethicon).Complications included two peroperative bleedings (n=1) and uterine perforation (n=1).A systematic abdominal ultrasound-guided metroplasty by hysteroscopy seems to reduce the rates of re-intervention.

• Brand Name: VERSAPOINT ELECTRODE UNKNOWN PRODUCT
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-GYRUS MEDICAL LTD; fortran road; cardiff
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9242229
• MDR Text Key: 167203361
• Report Number: 2210968-2019-89073
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040302
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: VERSAUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• 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