Date Initiated by Firm | November 03, 2014 |
Date Posted | November 25, 2014 |
Recall Status1 |
Terminated 3 on February 03, 2015 |
Recall Number | Z-0437-2015 |
Recall Event ID |
69638 |
510(K)Number | K131861 |
Product Classification |
System,surgical,computer controlled instrument - Product Code NAY
|
Product | 8MM PERMANENT CAUTERY SPATULA,;
Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. |
Code Information |
Part number 470184-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings. |
Recalling Firm/ Manufacturer |
Intuitive Surgical, Inc. 1266 Kifer Rd Bldg 100 Sunnyvale CA 94086-5304
|
For Additional Information Contact | Mark Johnson 408-523-2100 |
Manufacturer Reason for Recall | Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument. |
FDA Determined Cause 2 | Labeling design |
Action | Urgent Medical Device Recall letters were sent to affected sites on November 3, 2014. Letters inform customers of the reason for recall, risk to health and the affected instrument. A table of all of the affected IS4000 instruments affected is attached to the letter indicating the part number and product name for each. Letters also inform customers that all instruments shipped since July 2014 are manufactured with a new material and not subject to recall.
Customers are to take the following actions:
1. Ensure that all affected personnel are aware of the information.
2. Identify affected product in their possession
3. Contact ISI rep for replacement.
4. Complete and return the attached Acknowledgement From.
Until replacement instruments are received, the old instruments may be used provided they do not show signs of degradation and that the reprocessing instructions are followed. Questions to 800-876-1310 Option 3 ( 6 am to 5 pm PST) or ics@intusurg.com. |
Quantity in Commerce | 509 total units - all affected devices |
Distribution | US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = NAY
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