MAUDE Adverse Event Report: ETHICON INC. VERSAPOINT ELECTRODE; HYSTEROSCOPE(AND ACCESSORIES)

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

Patient Problem Hypervolemia (2664)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (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.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) involved caused and/or contributed to the post-operative complications ( fluid overload of over 2l ) described in the article? does the surgeon believe there was any deficiency with the ethicon product (versapoint) involved?.

Event Description

It was reported in a journal article entitled: a ¿¿see and treat¿¿ office procedure for retained products of conception removal after normal vaginal delivery using manual vacuum aspiration: preliminary efficacy and reproductive outcomes.The aim of this retrospective cohort study was to compare the efficacy and reproductive outcomes of an ultrasound-guided manual vacuum aspiration (mva) procedure with the widely accepted operative hysteroscopic (oh) procedure in the removal of retained products of conception (rpocs) after normal vaginal delivery.Eighty-six women patients after normal vaginal delivery at term (>37 weeks) diagnosed with suspected rpocs by either sonographic or diagnostic hysteroscopy and treated by either mva or oh from january 2005 through december 2015.Of 86 patients, 23 underwent remnant removal by ultrasound-guided mva using a 6 ¿ 7 mm catheter in a ¿¿see and treat¿¿ office procedure.63 patients (mean age 31.73 ± 5.99 years) underwent remnant removal using the oh procedure.The oh procedure was performed using a gynecare versapoint bipolar system (ethicon) with normal saline solution for uterine distention and constant observation for fluid in-out balance.Intraoperative reported complication included fluid overload of over 2l (n=1) which the procedure was terminated without complete removal of the remnant.Further intervention was needed and 4 weeks later, success of oh treatment was then observed.In conclusion, based on the preliminary results, the sonography-guided mva procedure for the removal of rpocs is a safe and efficient procedure with satisfactory reproductive outcomes.It does not require anesthesia or operating room facilities, allowing an immediate and inexpensive ¿see and treat¿ option for rpocs.

Manufacturer Narrative

Additional information was requested, and the following was obtained: 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 ( fluid overload of over 2l ) described in the article? does the surgeon believe there was any deficiency with the ethicon product (versapoint) involved? answers: the case presented did not involve, to the best of our knowledge a deficiency with the ethicon product.

• Brand Name: VERSAPOINT ELECTRODE
• Type of Device: HYSTEROSCOPE(AND ACCESSORIES)
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9209676
• MDR Text Key: 167346076
• Report Number: 2210968-2019-88523
• 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,literature
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention