Events

Recall of Device Recall Olympus Trocar Spikes

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olympus America 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
    54634
  • Event Risk Class
    Class 2
  • Event Number
    Z-1163-2010
  • Event Initiated Date
    2010-02-08
  • Event Date Posted
    2010-03-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88853
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Endoscope and/or accessories - Product Code KOG
  • Reason
    Weak weld seams.
  • Action
    The recalling firm issued a Medical Device Recall letter dated February 8, 2010, informing their customers of the problem and the need to return the product.

Device

Device Recall Olympus Trocar Spikes
  • Model / Serial
    Lot numbers: 075W, 076W, 077W, 078W, 081W, 083W, 084W, 07XW, and 07YW
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide: AL, AR, CA, FL, MI, MN, MO, NY, PA, OH, TX, and WY. Foreign: Canada
  • Product Description
    Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L || Used in conjunction with a compatible trocar tube, trocar tubes are used for intraperitoneal access during laparoscopic access during laparoscopic applications, and enable the passage of endoscopes and other diagnostic and therapeutic tools through the abdominal wall.
  • Manufacturer
    Olympus America Inc.

Manufacturer

Olympus America Inc.
  • Manufacturer Address
    Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA