| |
Class 2 Device Recall da Vinci Surgical System, Model IS4000 |
 |
| Date Initiated by Firm |
December 04, 2018 |
| Create Date |
February 06, 2020 |
| Recall Status1 |
Terminated 3 on August 24, 2022 |
| Recall Number |
Z-1105-2020 |
| Recall Event ID |
83994 |
| 510(K)Number |
K131861
|
| Product Classification |
System, surgical, computer controlled instrument - Product Code NAY
|
| Product |
Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI: (00) 886874112298 |
| Code Information |
Serial Number/Manufacturing Lot: N11181003, N11181004 |
Recalling Firm/
Manufacturer |
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 101
Sunnyvale CA 94086-5304
|
| For Additional Information Contact |
Peper Long
408-523-8083
|
Manufacturer Reason
for Recall |
This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not recognized by the integrated electrosurgical unit, which prohibits the activation of monopolar energy from the surgeon console.
|
FDA Determined
Cause 2 |
Nonconforming Material/Component |
| Action |
On 12/4/2018 date, the firm provided consignees a "Urgent Medical Device Recall" letter. The letter informed customers about the recall. In addition to providing information about the recall, the letter asked customers to do the following:
1.Locate and return all affected instruments in your inventory via the standard Intuitive RMA process as soon as possible.
2. Inform affected personnel when the return has been completed.
3. Please log into the da Vinci Online Community Field Action resource to read or complete any requested actions related to this issue, at this link:
https://www.davincisurgerycommunity.com/
4. In the case where the da Vinci online resource cannot be used, complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form.
5. Please retain a copy of this letter and the acknowledgement form for your files.
6.If you need further information or support concerning this Medical Device Recall, please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below:
¿ North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com. |
| Quantity in Commerce |
286 Monopolar curved scissors |
| Distribution |
US National Distribution
Alabama,
Arizona,
California,
Colorado,
Connecticut,
Delaware,
Florida,
Georgia,
Illinois,
Indiana,
Iowa,
Kentucky,
Louisiana,
Maryland,
Massachusetts,
Michigan,
Minnesota,
Missouri,
Montana,
Nebraska,
Nevada,
New Hampshire,
New Jersey,
New York,
North Carolina,
Ohio,
Oklahoma,
Oregon,
Pennsylvania,
Tennessee,
Texas,
Vermont,
Virginia,
Washington,
West Virginia,
Wisconsin,
Wyoming
OUS:None |
| 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.
|
|
|
|
