Reported Nov 6, 2013 · Terminated
Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 100 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 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, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.
- Lot codes and dates
- Model number 428088-12 All distribution from 3-15-13 to 7-19-13. Batch/Lot #Batch/Lot #
62 of 62 codes
S10130521S10130405S10130401S10130405S10130405S10130521S10130405S10130405S10130406S10130406S10130411S10130411S10130613S10130405S10130327S10130327S10130319S10130319S10130626S10130703S10130405S10130319S10130521S10130613S10130502S10130405S10130401S10130406S10130521S10130613S10130502S10130406S10130411S10130405S10130327S10130412S10130613S10130314S10130411S10130327S10130327S10130411S10130406S10130613S10130626S10130412S10130521S10130405S10130405S10130314S10130401S10130411S10130626S10130703S10130703S10130703S10130626S10130613S10130502S10130401
Batch/Lot #62 of 62 codes
S10130412S10130405S10130412S10130314S10130319S10130502S10130613S10130405S10130314S10130405S10130405S10130613S10130709S10130703S10130314S10130319S10130319S10130314S10130412S10130521S10130626S10130411S10130405S10130521S10130405S10130319S10130319S10130319S10130405S10130405S10130405S10130314S10130314S10130314S10130314S10130319S10130319S10130319S10130319S10130314S10130314S10130314S10130405S10130327S10130327S10130405S10130405S10130412S10130405S10130327S10130406S10130406S10130406S10130613S10130502S10130613S10130502S10130521S10130502S10130613
68 of 68 codes
S10130412S10130521S10130521S10130521S10130521S10130613S10130521S10130405S10130401S10130405S10130405S10130613S10130613S10130703S10130703S10130319S10130319S10130626S10130703S10130405S10130405S10130405S10130405S10130521S10130521S10130405S10130327S10130406S10130412S10130412S10130411S10130401S10130405S10130521S10130502S10130406S10130613S10130411S10130613S10130613S10130405S10130401S10130327S10130405S10130406S10130405S10130405S10130405S10130319S10130319S10130406S10130406S10130703S10130613S10130502S10130412S10130412S10130406S10130406S10130521
- Model number 428088-12 All distribution from 3-15-13 to 7-19-13. Batch/Lot #
- Amount recalled
- 504 devices for a total of 2,220 affected clinical product.
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Intuitive Surgical, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.