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 Pain (1994); Uterine Perforation (2121); No Code Available (3191)

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 (2018) 00, 1-8; doi: https://doi.Org/10.1016/j.Jmig.2018.12.002.

Event Description

Title: effectiveness of hysteroscopic techniques for endometrial polyp removal: the italian multicenter trial.The aim of this prospective study was to compare the effectiveness and safety of different techniques of hysteroscopic polypectomy.Between january and december 2016, 1519 patients underwent hysteroscopic single/ multiple polypectomy, but 1404 (mean age 52.37 ± 12.65 years; mean bmi 24.97 ± 4.6 kg/m^2) were included in the study.Hysteroscopic polypectomy was performed by using 1 of the following instruments: double-flow 12fr or 16fr lens-based rigid hysteroscopes with 5fr operative channels, 26fr to 27fr resectoscopes armed with either monopolar or bipolar loops (versapoint bipolar system, gynecare; ethicon), 16fr monopolar/bipolar resectoscope, fiber-based 3.5-mm hysteroscope (versascope, gynecare; ethicon, inc.) with 7fr operative channel, or 13fr hysteroscopic morcellation system.Cutting instruments included mechanical tools (sharp scissors, grasping forceps, morcellators), electric tools 5fr coaxial bipolar disposable electrodes (versapoint bipolar system, gynecare), reusable electrodes bipolar loops or miniloops, monopolar loops or miniloops, and polyfiber diode laser probes.Surgical complications included perforation (=?); vasovagal syndrome (n=?); severe pelvic pain -vas >6 (n=5); penetration (n=?).In conclusion, outpatient polypectomy was associated with a minimal but significantly higher risk of residual endometrial polyps (eps) in comparison with inpatient polypectomy.Conversely, inpatient polypectomy was associated with a considerably higher risk of uterine perforation and penetration in comparison with office hysteroscopy.Because of lower intraoperative risks and higher cost effectiveness, office hysteroscopy may be considered, whenever possible, as the gold standard technique for removing eps.

Manufacturer Narrative

Date sent to the fda: 01/09/2020.

Manufacturer Narrative

Date sent to the fda: 1/9/2020.Additional information was requested, and the following was obtained: were the cases discussed in this article previously reported to ethicon? the cases discussed in this article were not previously reported to ethicon.Does the surgeon believe there was any deficiency with the ethicon product (versapoint) involved? versapoint did not show any deficiency.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the surgeon believe that specific ethicon product such as versapoint electrodes/loops involved caused and/or contributed to the post-operative complication described in the article?.

• 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
• MDR Report Key: 9241718
• MDR Text Key: 167438888
• Report Number: 2210968-2019-89065
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2019

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: 12/13/2019
• Patient Sequence Number: 1
• Treatment: UNK_VERSAPOINT RESECTOSCOPE.
• Patient Outcome(s): Required Intervention