Events

Recall of PENTAX VB-2000 VIDEO BRONCHOSCOPE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PENTAX CANADA 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
    98635
  • Event Risk Class
    II
  • Event Initiated Date
    2017-07-10
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Pentax medical has become aware that some customers may own legacy endoscopes where the screw connecting the suction arm to the control body could loosen with time. a loose suction arm may result in inadequate suctioning due to leakage of air. there is also the potential for organic debris to accumulate in the space between the suction nipple and control body. in some cases these events could cause cross-contamination between patients.

Device

PENTAX VB-2000 VIDEO BRONCHOSCOPE
  • Model / Serial
    Model Catalog: EB-1970TK (Lot serial: G111020); Model Catalog: EB-117OK (Lot serial: G110123); Model Catalog: EB-1970K (Lot serial: G110123); Model Catalog: EB-1970TK (Lot serial: G110123); Model Catalog: EB-117OK (Lot serial: G110458); Model Catalog: EB-1570K (Lot serial: G110458); Model Catalog: EB-1970K (Lot serial: G110458); Model Catalog: EB-1970TK (Lot serial: G110458); Model Catalog: EB-117OK (Lot serial: G110907); Model Catalog: EB-1570K (Lot serial: G110907); Model Catalog: EB-1970K (Lot serial: G110907); Model Catalog: EB-1970TK (Lot serial: G110907); Model Catalog: EB-117OK (Lot serial: G110589); Model Catalog: EB-1570K (Lot serial: G110589); Model Catalog: EB-1970K (Lot serial: G110589); Model Catalog: EB-1970TK (Lot serial: G110589); Model Catalog: EB-117OK (Lot serial: G110017); Model Catalog: EB-1570K (Lot serial: G110017); Model Catalog: EB-1970K (Lot serial: G110017); Model Catalog: EB-1970TK (Lot serial: G110017); Model Catalog: EB-117OK (Lot serial: G110029); Model Catalog: EB-1570K (Lot s
  • Product Description
    PENTAX VB-2000 VIDEO BRONCHOSCOPE;E.N.T. SCOPE;SLIM CYSTOSCOPE SET
  • Manufacturer
    PENTAX CANADA INC.

Manufacturer

PENTAX CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    HC