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U.S. Department of Health and Human Services

Class 2 Device Recall Fluorescence Imaging Procedure Kits

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  Class 2 Device Recall Fluorescence Imaging Procedure Kits see related information
Date Initiated by Firm September 09, 2015
Date Posted September 17, 2015
Recall Status1 Terminated 3 on November 02, 2015
Recall Number Z-2782-2015
Recall Event ID 72158
510(K)Number K141077  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product 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.
Code Information 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.     
Recalling Firm/
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Mark Johnson
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Package design/selection
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
Quantity in Commerce 1200 kits
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.