Events

Recall of Device Recall Verspoint

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ethicon, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    30711
  • Event Risk Class
    Class 2
  • Event Number
    Z-0493-05
  • Event Initiated Date
    2004-12-16
  • Event Date Posted
    2005-02-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36436
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Hysteroscope (And Accessories) - Product Code HIH
  • Reason
    Deformation of the verspoint hysteroscopic system connector cable hand grips when autoclaved causing possible non-sterile electrodes.
  • Action
    The recall letter was mailed to the Director of Material Management and the Director of Operating Room on December 14, 2004.

Device

Device Recall Verspoint
  • Model / Serial
    Product Code: 00480; Lot #s:  0404086, 0404121, 0404152, 0405010, 0405123, 0406014, 0406068, 0406130, 0407104, 0408031, 0409029, 0409080, 0410021, 0410103, 0411040.
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Ethicon distributed the devices to 166 hospitals in the US. There are no Government sales. Product sold to other countries was distributed directly from the manufacturerin England to Ethicon distributors outside the US. The Foreign countries with accounts are: Austria, Czech Republic, Greece, Italy, Benelux, Poland, Portugal, Slovenia, Spain, Sweden, France, Germany, Ireland, U.K. Canada, China, Mexico, Taiwan, Venezuela, Korea, Australia, Brazil, and India.
  • Product Description
    VERSAPOINT, Hysteroscopic system Connector Cable, Non-Sterile, Reusable (20 uses only). US Distribution/Manufactured for GYNECARE, A division of Ethicon, Inc., a Johnson & Johnson Company, Somerville, NJ 08876. The product subject of this recall is the connector cable which goes between the electrosurgical generator and the elctrode used for surgery. Specifically, the recall focuses on the hand grip on the electrode, formed by overmolding a polymer onto the cable, which deforms upon sterilization.
  • Manufacturer
    Ethicon, Inc

Manufacturer

Ethicon, Inc
  • Manufacturer Address
    Ethicon, Inc, US Highway 22 West, Somerville NJ 08876
  • Source
    USFDA