Events

Recall of Fluorescence Imaging Procedure Kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Intuitive Surgical, 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
    72158
  • Event Risk Class
    Class 2
  • Event Number
    Z-2782-2015
  • Event Initiated Date
    2015-09-09
  • Event Date Posted
    2015-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140020
  • 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
    System,surgical,computer controlled instrument - Product Code NAY
  • Reason
    B. braun 2 gang 4-way stopcocks in the fluorescence imaging procedure kit may experience damage to the sterile packaging during shipping. the damage can result in tears to the packaging and has the potential to cause a breach in sterility of the supplied stopcocks.
  • Action
    Intuitive sent an Urgent Medical Device Correction letters dated September 9, 2015 to all customers via traceable method. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to : 1. Ensure that all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff, anesthesiologist and members of your medical staff who perform da Vinci Surgery procedures. 2. Prior to use, open and inspect current supply of Fluorescence Imaging Procedure Kits. If kits include B. Braun stopcocks, discard stopcocks and replace with other stopcocks 3. Continue to perform procedures using other stopcocks 4. Continue to follow directions provided in Florescence Imaging Procedure Kit IFU (p/n 550976), If a sterile item in a Fluorescence Imaging Procedure Kit becomes compromised in any way, do not use the compromised item; replace it with a new item. 5. Complete and return the attached Acknowledgment Form to Intuitive Surgical using the instructions provided. 6. Please retain a copy of this notice near your Fluorescence Imaging Procedure Kit inventory. Questions or concerns should be directed to Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: " (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail: customersupportservicesupport@intusurg.com

Device

Fluorescence Imaging Procedure Kits
  • Model / Serial
    Product number: 950156-01: Lot numbers: NQ141201 NQ141502 NQ142201 NQ142901 NQ143201 NQ143301.  Product number 950156-02: Lot numbers: NQ143501 NQ143502 NQ143601 NQ143602 NQ143803 NQ143901 NQ143902.  Product number 950156-03: Lot numbers : NQ144001 NQ150501  NQ143902 NQ150601  NQ143901 NQ150602  NQ143803 NQ150703  NQ143601 NQ150701  NQ143602 NQ150702  NQ144502 NQ150801  NQ144801 NQ150901  NQ145202 NQ150802  NQ144901 NQ151001  NQ145301 NQ151002  NQ145201 NQ151101  NQ150301 NQ150501  NQ144001.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; || Model numbers: 950156-01, 950156-02, 950156-03. || Product Usage: General and plastic surgery: The da Vinci Firefly Imaging system is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging.
  • Manufacturer
    Intuitive Surgical, Inc.

Manufacturer

Intuitive Surgical, Inc.
  • Manufacturer Address
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Manufacturer Parent Company (2017)
    Intuitive Surgical Inc
  • Source
    USFDA