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 Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(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: research journal of obstetrics and gynecology (2020);13(1):1-7.Doi: 10.3923/rjog.2020.1.7.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported in a journal article with title: endometrial ablation for dysfunctional uterine bleeding in low-resource settings: a randomized controlled trial.The objective of this open-label randomized controlled prospective study was to compare the efficacy and safety profile of bipolar resectoscopic endometrial ablation (rea) and non-resectoscopic endometrial ablation modalities (nrea) i.E., thermal ablation by modified foley's catheter and chemical ablation using tca.Between may 2016 to may 2019, a total of 150 women underwent endometrial ablation due to dysfunctional uterine bleeding (dub).These patients were randomly allocated as follow: 50 patients (mean age of 44.9±4.8 years; mean bmi of 29.1±7.8) managed by hysteroscopic endometrial resection using a versapoint, 50 patients (mean age of 45.7±5.1 years; mean bmi of 30.3±8.5) managed by thermal balloon ablation, and 50 patients (mean age of 46.5±4.5 years; mean bmi of 30.9±8.4) managed by trichloroacetic acid (tca) were assigned to chemical group.Reported complications include vaginal bleeding (n=2), worsening of menstrual flow (n=1), unchanged menstrual flow (n=4), and not satisfied (n=7).In conclusion, both thermal and chemical methods of endometrial ablation were as effective as rea in the management of dub and had a significant shorter operative time and shorter hospital stay with more rapid return to daily and sexual activity.Chemical endometrial ablation can be performed without general anesthesia especially for highly risk patients and in low resource settings.

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: research journal of obstetrics and gynecology (2020);13(1):1-7.Doi: 10.3923/rjog.2020.1.7.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported in a journal article with title: endometrial ablation for dysfunctional uterine bleeding in low-resource settings: a randomized controlled trial.The objective of this open-label randomized controlled prospective study was to compare the efficacy and safety profile of bipolar resectoscopic endometrial ablation (rea) and non-resectoscopic endometrial ablation modalities (nrea) i.E., thermal ablation by modified foley's catheter and chemical ablation using tca.Between may 2016 to may 2019, a total of 150 women underwent endometrial ablation due to dysfunctional uterine bleeding (dub).These patients were randomly allocated as follow: 50 patients (mean age of 44.9±4.8 years; mean bmi of 29.1±7.8) managed by hysteroscopic endometrial resection using a versapoint, 50 patients (mean age of 45.7±5.1 years; mean bmi of 30.3±8.5) managed by thermal balloon ablation, and 50 patients (mean age of 46.5±4.5 years; mean bmi of 30.9±8.4) managed by trichloroacetic acid (tca) were assigned to chemical group.Reported complications include vaginal bleeding (n=2), worsening of menstrual flow (n=1), unchanged menstrual flow (n=4), and not satisfied (n=7).In conclusion, both thermal and chemical methods of endometrial ablation were as effective as rea in the management of dub and had a significant shorter operative time and shorter hospital stay with more rapid return to daily and sexual activity.Chemical endometrial ablation can be performed without general anesthesia especially for highly risk patients and in low resource settings.

• 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: 12763531
• MDR Text Key: 285226462
• Report Number: 2210968-2021-10991
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• 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