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 Adhesion(s) (1695); 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 gynecology obstetrics & reproductive biology (2015) 44, 658-664; doi: http://dx.Doi.Org/10.1016/j.Jgyn.2014.09.006.(b)(4).

Event Description

Title: operative hysteroscopy for myoma removal: morcellation versus bipolar loop resection.The aimed of this retrospective comparative study was to evaluate the results associated with hysteroscopic morcellation for submucous myomas removal, and to compare with those observed associated with bipolar loop resection.Between january 2012 and december 2013, 83 patients underwent resection of type 0, 1, and 2 submucous myomas.The patients were divided into two groups in which 34 patients were in morcellation group and 49 patients (age range 40.2 ± 7.6 years; bmi range 23.1 ± 3.2 kg/m^2) were in the versapoint 24f bipolar loop (gynecare, ethicon) resection group.In 24f bipolar hysteroscopy, the hysteroscope is composed to two sheaths: an inner one for irrigation and moving the loop around and an outer sheath for aspiration.Reported complications included bleeding (n=5) in which the bleeding was not deemed severe in 4 cases, with regression of the bleeding after intravenous injection of syntocinon; uterine perforation (n=2); synechia (n=4).In conclusion, this comparative series, loop resection and hysteroscopic morcellation of submucous myomas proved to be two techniques that are equivalent in terms of complete resection, operating time, or the prevalence of complications.However, hysteroscopic morcellation seems to be more suited to type 0 and 1, non-fundal and non-calcified myomas.

• 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: 9242408
• MDR Text Key: 167439883
• Report Number: 2210968-2019-89076
• 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