Events

Recall of Device Recall Endoscope Video Imaging System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Novadaq Technologies 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
    73225
  • Event Risk Class
    Class 2
  • Event Number
    Z-1032-2016
  • Event Initiated Date
    2016-01-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143596
  • 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
    Laparoscope, general & plastic surgery - Product Code GCJ
  • Reason
    It has been determined that the pinpoint operator's manual does not contain validated parameters for gravity-cycle autoclave sterilization of the pinpoint laparoscopes and light guide cable in the reprocessing tray.
  • Action
    Novadaq sent an Urgent Device Correction letter dated February 2, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Recipients of this notice have received shipments that include the inaccurate Operator's Manual. Please follow these instructions: 1. Discard any old PINPOINT Operator's Manuals Rev J through M. 2. Accept and review the new PINPOINT Operator's Manual (Rev N). 3. Complete and sign the enclosed "Acknowledgement of Receipt" form, scan it and email to PI NPOINT@novadaq.com. Any questions or concerns may also be sent to this address. For further questions, please call 1-(844) 668-2327, ( Select Option # 1)

Device

Device Recall Endoscope Video Imaging System
  • Model / Serial
    Rev. J, Rev. K, Rev. L and Rev. M  Model Number : PC9000
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.
  • Product Description
    PINPOINT Endoscopic Fluorescence Imaging System
  • Manufacturer
    Novadaq Technologies Inc.

Manufacturer

Novadaq Technologies Inc.
  • Manufacturer Address
    Novadaq Technologies Inc., 8329 Eastlake Dr Unit 101, Burnaby Canada
  • Manufacturer Parent Company (2017)
    Novadaq Technologies Inc.
  • Source
    USFDA