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 Unspecified Infection (1930); 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.Citation: bjog: an international journal of obstetrics and gynaecology.2013 jun; 120 (suppl.1) :396; http://dx.Doi.Org/10.1111/1471-0528.12300.(b)(4).

Event Description

Title: operative outpatient hysteroscopy: the way forward.The objective of this retrospective study was to look at patient profiles, complications and success rates of all the operative outpatient hysteroscopy cases which mainly included versapointtm polypectomies and thereby confirm feasibility of this procedure as the main stay of management of such cases.Between 01ja2010 and 31dec2011, a total of 75 patients were included in the study but only 68 case notes were obtained.Seventy-nine percent cases polyps were removed using the versascopetm (ethicon) and versapointtm system (ethicon).Reported complication included infection and bleeding (n=1).In conclusion, majority of patients were successfully managed in the outpatient department thereby reducing waiting times, avoiding unnecessary admissions, freeing up valuable theatre time, also averting anaesthetic problems related to patients with high bmi and significant medical problems and also much quicker turnover of patients.

• 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: 9239033
• MDR Text Key: 167441747
• Report Number: 2210968-2019-89054
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• 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: 09/27/2019

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: Health Professional
• Device Catalogue Number: VERSAUNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/25/2019
• 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