Recall Z-1425-2013— Intuitive Surgical, Inc.

Name: FDA recall Z-1425-2013
Creator: U.S. Food and Drug Administration
Published: 2011-09-23

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2011-09-23, terminated 2013-05-30. It names one FDA 510(k) clearance: K050005. Product: Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.. Reason: Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2011-09-23
Terminated: 2013-05-30
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K050005 — INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180Intuitive Surgical, Inc.·cleared 2005-01-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable Tip cover accessory is used in conjunction with the 8mm Monopolar Curved Scissors Instruments to cut and coagulate tissue. The tip cover is intended to provide electrical insulation over a section of the Monopolar Curved Scissors instrument so that FR energy is only available at the scissors blades.

Reason for recall

Clarification of existing labeling and related cautions for the tip cover accessory of the da Vinci Surgical System.

Data sourced from openFDA. This site is unofficial and independent of the FDA.