MAUDE Adverse Event Report: ETHICON INC. VERSAPOINT SPRING TIP ELECTRD; HYSTEROSCOPE (AND ACCESSORIES)

Catalog Number 00471

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The single complaint was reported with multiple events through a journal article.No specific patient information regarding events has been provided and it is unknown if the events have been previously reported.Attempts are being made to obtain the following information.If further details are received at the later date a supplemental medwatch will be sent.Authors : alessandro casa, m.D., francesco sesti, m.D., massimiliano marziali, m.D., lorenza gulemì, m.D., and emilio piccione, m.D.Citation: j am assoc gynecol laparosc.2003; 10(2): 219¿222.

Event Description

It was reported in a journal article entitled: transvaginal hydrolaparoscopic ovarian drilling using bipolar electrosurgery to treat anovulatory women with polycystic ovary syndrome.The objectives of this study was to verify the value, feasibility, and reliability of transvaginal hydrolaparoscopic ovarian drilling using the bipolar versapoint system (ethicon) to treat clomiphene-resistant, anovoluntary women with polycystic ovary syndrome.A total of 28 female patients (age: 29.3 ± 4.2 years; bmi: 25.3 ± 5.4) were included in the study.The bipolar gynecare versapoint electrosurgical system (ethicon) was used during the procedure.Reported complications included ovarian bleeding (n-1) which required conversion to conventional laparoscopy and was excluded from the study and lysis of the peri-ovarian adhesions (n-1) which was associated with the ovarian drilling.Transvaginal hydrolaparoscopic ovarian drilling with the bipolar versapoint system allowed safe management in these anovulatory women with pcos resistant to medical treatment.Further randomized trials between laparoscopic and hydrolaparoscopic ovarian drilling are necessary to define more precisely the procedures¿ respective indications and limits.

• Brand Name: VERSAPOINT SPRING TIP ELECTRD
• 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; st mellons; cardiff ; UK
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9172623
• MDR Text Key: 161842928
• Report Number: 2210968-2019-88507
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K040302
• 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: 09/16/2019

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: No Information
• Device Catalogue Number: 00471
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention