Recalling Firm / Manufacturer

Intuitive Surgical Inc.

Product

5mm Curved Scissors.

Description

5 mm Curved Scissors Used with da Vinci Surgical Systems.

They designed to cut tissue and/or material during surgical procedures. These scissors are typically hand-held, manual instruments with two metallic (e.g., stainless steel) blades with sharp edges that slide past each other (i.e., shearing action). The blades are usually attached to handles with the proximal end conformed as a ring to facilitate holding and operating with the fingers; both parts are joined by a swivel pin in the center. Some surgical scissors intended for delicate procedures (e.g., ophthalmic, neurosurgery, microsurgery) have flat handles with serrations to provide a safer grip and inserted flat springs, avoiding uneven tension and providing a more uniform and/or sensitive manipulation. Small fine scissors with sharp blades are used to cut and dissect soft tissue; heavy-duty scissors are used for cutting stronger tissue such as tendons and cartilage; dedicated surgical scissors with a variety of tips and blades are available for particular procedures (e.g., ophthalmic, abdominal, arteriotomy, obstetric).

PART NUMBER

LOT NUMBERS

Code Information

420146-04

1010071, 1302071, 1307071, 1309071, 1705071, 202071, 2806071, 3005071, 711131, 712131, 802121, 803261, 805221, 806071, 904071, 907071, S10080619, S10080630, S10080710, S10080826, S10080905, S10080916, S10080926, S10081106, S10081125, S10081223, S10090105, S10090204, S10090226, S10090320, S10090416, S10090430, S10090605, S10090630, S10090715, S10090818, S10090818, S10090829, S10090902, S10090915, S10090921, S10090925, S10091006, S10091006, S10091104, S10091109, S10091113

400146-11

1201071, 1206071, 2105071, 2211061, 3005071

400146-12

S10090116, 507071, 710291, 802111, 804071 805191

Reason of Recall

Intuitive Surgical has become aware of a defect involving the size and shape of the blades and this defect may cause premature dulling of the scissors potentially shortening the life expectancy of the instrument. This defect has been corrected and newly manufactured 5mm, Curved Scissors instruments are currently in distribution

Date Recall Initiated

January 28, 2010

Action

This issue carries no risk to patient because premature dull scissors shall require being removed and replaced during the procedure. This is minor impact and will not present a risk to the patient. A CAPA 1337 has been opened to address root cause analysis and corrective /preventive actions. Customer notifications are sent to distributors and users advising of the issue. Customers are requested to review current inventories, identify and isolate affected material and return affected material to Intuitive Surgical.

Contact

Gulf Medical Co.
Riyadh
(01) 4633399

Source

NCAR , MHRA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.