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 Pain (1994); Solid Tumour (4552)

Event Date 06/28/2020

Event Type  Injury  

Event Description

It was reported in a journal article with title: comparison of endometrial polyp recurrence in fertile women after office hysteroscopic endometrial polypectomy using two widely spread techniques.This study aimed to compare the recurrence of benign endometrial polyps after office hysteroscopic polypectomy performed with a bipolar electrode (be) or a small diameter hysteroscopic tissue removal system (htrs).From july 2018 to december 2019 we evaluated the charts of 114 asymptomatic fertile women who underwent office hysteroscopic polypectomy, 1 year before, for a single large benign endometrial polyp (size between 10 and 20 mm) using a 4 mm continuous flow hysteroscope with a 5 fr be (type twizzle, versapoint, gynecare) or a 5.6 mm oval profile htrs truclear 5c system, medtronic) with a 2.9-mm blade.In 61 out of 114 women (be group) polyps were removed using a 4-mm diameter continuous-flow hysteroscope with oval profile and a 30 fore-oblique telescope and a 5 fr operating channel (office continuous flow operative hysteroscope ¿size 4¿, karl storz).The 5 fr be (type twizzle, versapoint, gynecare) was introduced in the operative channel and connected by a flexible cable to a generator that was automatically set to vapor cut 3, corresponding to the mildest energy flowing into the tissue, and also reducing by half the power setting to 50 w (vc3-50).5 polyps were sliced from the free edge to the base into two/three fragments, large enough to be pulled out through the uterine cavity using 5 fr grasping forceps with teeth.To remove the entire base of the polyp without going too deep into the myometrium, in some cases, the twizzle electrode was bent by 25 ¿30, enough to obtain a kind of hook electrode.Distension of the uterine cavity was obtained with saline solution (nacl 0.9%), using an electronic suction-irrigating pump (endomat, karl storz).A stable intrauterine pressure of approximately 40 mmhg was obtained by setting the flow rate at 300¿350 ml/min, the negative pressure suction at 0.2 bar and the pressure of irrigation at 100/120 mmhg.Patients were scheduled for a 12-month postoperative transvaginal sonography to evaluate the recurrence of endometrial polyps.Only women who had not been pregnant after the polypectomy were considered eligible for the study.Seven (14.6%) out of 48 women of the be group reported moderate pain (vas score between 5 and 7).Three recurrent polyps in the be group were in the same position as those removed 1 year before.Since the three polyps of be group were flat and located in the fundus of the uterine cavity, the recurrence could be linked to an incomplete stalk removal.All recurrent polyps were hysteroscopically removed and confirmed as ¿benign¿ by the pathologist.No other coexisting pathology was detected in the uterine cavity during hysteroscopic evaluation.Reported complication included n=3 recurrent polyps and n=7 pain (vas score= 5-7).In conclusion, office hysteroscopic endometrial polypectomy with small htrs compared to be revealed at a 1-year follow-up no difference in terms of complete removal and recurrence of polyps.Htrs polypectomy resulted in less pain and significantly quicker time of procedure compared to be.This data should be kept in mind for patient comfort any time hysteroscopic polypectomy is planned in an office setting.

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: doi:10.1111/jog.14400 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.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 electrode) 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 involved? patient demographics?.

• 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: 12759609
• MDR Text Key: 284528803
• Report Number: 2210968-2021-10962
• 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,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/07/2021
• 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 Outcome(s): Required Intervention
• Patient Sex: Female