Events

Recall of Device Recall Olympus OFP Flushing Pump irrigation tubing

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
    60613
  • Event Risk Class
    Class 3
  • Event Number
    Z-0806-2012
  • Event Initiated Date
    2011-12-12
  • Event Date Posted
    2012-01-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105979
  • 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
    Pump, air, non-manual, for endoscope - Product Code FEQ
  • Reason
    Water may leak from the irrigation tubing used on the olympus flushing pump.
  • Action
    The firm,Olympus, sent an "URGENT-DEVICE CORRECTION " letter dated December 12, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were informed that any current irrigation tubing in their inventory can be used with the OFP pump; however, they must inspect the tubing installed on the OFP pump for signs of water leakage; if leakage is found, discontinue use of the tubing and replace with a new irrigation tube. In addition, complete and return the enclosed questionnaire via fax to (484) 896-7128. If you do not wish to use your current inventory of irrigation tubing and would like a replacement, call Olympus Customer Care Center at 1-800-848-9024. Olympus is discontinuing the current version of irrigation tubing and has redesigned the irrigation tubing to prevent water leakage. For any additional information, contact the V.P., Regulatory/Clinical Affairs & Quality Assurance at (484) 896-5688 or email at laura.storms-tyler@olympus.com.

Device

Device Recall Olympus OFP Flushing Pump irrigation tubing
  • Model / Serial
    Catalog number 7501669
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA including states of: AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, AND WY.
  • Product Description
    Olympus OFP Flushing Pump irrigation tubing || The Olympus OFP Flushing Pump is a peristaltic flushing pump intended for use with Olympus gastrointestinal videoscopes having an auxiliary water inlet as part of an Olympus endoscopic imaging system to facilitate washing of gastric and colonic mucosa to remove blood, feces and other organic matter, enabling improved visualization, diagnosis and therapy during endoscopic procedures.
  • 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