Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems; Model numbers: 950156-01, 950156-
FDA device recall Z-2782-2015 · posted 2015-09-17 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- 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.
- Action taken
- 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
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 1200 kits
- Distribution
- US Nationwide Distribution
- Date initiated
- 2015-09-09
- Date posted
- 2015-09-17
- Date terminated
- 2015-11-02
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DA VINCI FIREFLY IMAGING SYSTEM (K141077) | Intuitive Surgical, Inc. | 2014-08-12 |