Events

Recall of MAJ1606 Instrument Channel Adaptor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olympus Corporation of the Americas.

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
    72242
  • Event Risk Class
    Class 2
  • Event Number
    Z-0113-2016
  • Event Initiated Date
    2015-09-11
  • Event Date Posted
    2015-10-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140321
  • 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
    Small puncture marks in a sterile package for an accessory to an olympus device.
  • Action
    A letter of urgent device safety information, dated September 18, 2015, was sent to direct customers to inform them of the issue and instructions to cease use immediately. Customers were also asked to return the completed response form along with affected devices.

Device

MAJ1606 Instrument Channel Adaptor
  • Model / Serial
    Models: Part number K10016901 is a package of 10 pieces, Part number K10007072 is a package of 100 pieces   Part number K10016901: lot numbers 20115441, 20116536, Part number K10007072: lot numbers 20115441, 20116536
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) and Canada.
  • Product Description
    MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connection between the endoscope's instrument channel port and the O FP-2 pump's tubing.
  • Manufacturer
    Olympus Corporation of the Americas

Manufacturer

Olympus Corporation of the Americas
  • Manufacturer Address
    Olympus Corporation of the Americas, PO Box 610, 3500 Corporate Pkwy, Center Valley PA 18034-8229
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA