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U.S. Department of Health and Human Services

Class 2 Device Recall Maryland Dissector

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  Class 2 Device Recall Maryland Dissector see related information
Date Initiated by Firm August 08, 2015
Date Posted September 10, 2015
Recall Status1 Terminated 3 on December 03, 2015
Recall Number Z-2750-2015
Recall Event ID 72036
510(K)Number K112208  K122532  K130726  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product Maryland Dissector; used with the da Vinci Si Surgical System (IS3000);
Model numbers: 428050-12, 428050-13 and 428050-14;

The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
Code Information Model numbers: 428050-12. 428050-13 and 428050-14; all lots
Recalling Firm/
Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Mark Johnson
Manufacturer Reason
for Recall
In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
FDA Determined
Cause 2
Device Design
Action Intuitive Surgical sent an Urgent Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 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 and members of your medical staff who perform da Vinci Surgery procedures. 2. Replace any instrument that shows signs of damage and contact Intuitive Surgical Customer Service. 3. Complete and return the attached Acknowledgment Form to Intuitive Surgical using the instructions provided. 4. Please retain a copy of this notice as well as the attached instructions with your Single-Site User Manual. If you need further information or support concerning this issue, 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 (6 AM to 5 PM PST) or mail: customersupport-servicesupport@intusurg.com ¿ Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com ¿ South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) ¿ Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST) For questions regarding this recall call 408-523-2100.
Quantity in Commerce 8217 total units
Distribution Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, Chile, China, Cyprus, Denmark, France, Germany, Greece, Israel, Italy, Monaco, Netherlands, Panama, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.
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.