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 Fever (1858); Inflammation (1932); Pain (1994); Injury (2348); Not Applicable (3189)

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.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.Was the case 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? citation: acta obstetricia et gynecologica scandinavica 93 (2014) 218¿220 / doi: 10.1111/aogs.12274.(b)(4).

Event Description

Title : thermal injury to the sigmoideum following hysteroscopic hydrothermal ablation the purpose of this case report was to discuss thermal injury to the sigmoideum following hysteroscopic hydrothermal ablation.This was regarding a 39-year-old woman with a surgical history including laparoscopic enucleation of an endometrioma underwent hydrothermal endometrial ablation because of menorrhagia and severe dysmenorrhea.Hysteroscopy was performed exposing a small polyp with benign appearance, size 5 mm, in the posterior wall of the uterus.The polyp was removed with versapoint (ethicon).Hydrothermal ablation was started under hysteroscopy guidance and the procedure was carried out without any technical difficulties.After surgery, the woman suffered from an expected degree of abdominal pain, which was sufficiently treated with peroral (oral) analgesia.In the evening, the day after surgery, she suddenly experienced increasing abdominal pain and diarrhea.During the night she developed fever and in the morning she was immediately admitted to the hospital.She suffered from high fever, diarrhea and general abdominal pain but no peritonitis.The laboratory blood test showed normal hemoglobin concentration and very high level of inflammatory markers.The woman was immediately started on intravenous antibiotics.The woman¿s general condition deteriorated resulting in a decision for laparotomy.The intraoperative findings included intra-abdominal fluid, a pathological pale area on the sigmoideum, 1 cm in diameter, suggestive of heat injury, but no perforation.On the posterior wall of the uterus there was an equivalent pale area but no perforation.Drainage was left intra-abdominally.The woman recovered slowly and the drainage was removed 2 days postoperatively.Possible explanation for the induced injury to the serosa of the sigmoideum is the removal of the small polyp before the hydrothermal ablation.The removal most probably caused a weakening and thinning of the uterus wall, facilitating heat transmission through the myometrium.The temperature will drop while going through the tissue, which is why damage occurred only to the serosa of the sigmoideum.

Manufacturer Narrative

Additional information was requested and following obtained: questions: was the case 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? answers: versapoint is a reliable instrument to remove polyps with.There was nothing wrong with the specific article used in the case described in the report.However, the possible weakening of the uterine wall after removing a polyp with versapoint might increase the risk of heat transmission through the uterine wall or perforation of hot fluid if the endometrial ablation via circulating hot fluid is done in the same process.

• 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: 9239892
• MDR Text Key: 167436368
• Report Number: 2210968-2019-89056
• 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
• 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: 11/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR