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 Unspecified Infection (1930); Uterine Perforation (2121); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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.The manufacturing record evaluation cannot be reviewed as the lot number has not been provided.

Event Description

It was reported in a journal article entitled: transcervical incision of septa.This retrospective study aimed to evaluate feasibility and clinical value of hysteroscopic bipolar electric vaporization technique (versapoint bipolar electrosurgical system) used in transcervical incision of septa (tcis) in an outpatient setting.From (b)(6) 2001 to (b)(6) 2005, 447 patients with an average age of 29.17 ± 4.34 years (range 21¿53 years) underwent hysteroscopic tcis.Microscissors was used for 55 patients, monopolar electric needle was used for 15 patients, monopolar electric loop was used for 11 patients and bipolar electric vaporization electrode was used for 366 patients.Bipolar electric resectoscope (johnson & johnson inc., usa) and versapoint bipolar electrosurgical system (gynecare; ethicon inc., nj, usa) included special bipolar electrical generator with an output power at 40¿60 w and two types of evaporation electrodes: helical electrode and spring electrode (1.7 mm outer diameters) with the former used in accurate vaporization incision and the latter used in diffuse tissue vaporization.Complications included uterine perforation which was treated with uterine contraction agents; blood loss and injury to blood vessels in muscular tissue of uterine fundus which were treated with uterine contraction agents and hemostatics; postoperative pelvic infection and urethral infection which were treated with antibiotics.In conclusion, hysteroscopic bipolar electric vaporization tcis could be carried out safely and efficaciously in an outpatient setting, by using smaller hysteroscope and bipolar electrodes.

Manufacturer Narrative

(b)(4).Additional information: concomitant product - versapoint generator.

• 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: 9183748
• MDR Text Key: 162624967
• Report Number: 2210968-2019-88607
• 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: 10/14/2019
• 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: 11/15/2019
• Patient Sequence Number: 1
• Treatment: VERSAPOINT GENERATOR UNKNOWN PRODUCT
• Patient Outcome(s): Required Intervention