Events

Recall of Device Recall INVUITY PHOTON BLADE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Invuity, 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
    77607
  • Event Risk Class
    Class 2
  • Event Number
    Z-2778-2017
  • Event Initiated Date
    2017-06-12
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=156761
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients.
  • Action
    Official notices were sent to customers via FedEx overnight on 6/14/17. Email notices were sent to the sales personnel 06/12/2017 regarding the return of their trunk stock inventory and asking them to also contact customers who had been sent letters.

Device

Device Recall INVUITY PHOTON BLADE

Manufacturer

Invuity, Inc.
  • Manufacturer Address
    Invuity, Inc., 444 De Haro St, San Francisco CA 94107-2347
  • Manufacturer Parent Company (2017)
    Invuity Inc
  • Source
    USFDA