Recall Z-1117-2015— Intuitive Surgical, Inc.

Name: FDA recall Z-1117-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-21

Class II · Terminated

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2015-01-21, terminated 2015-06-01. It names one FDA 510(k) clearance: K093217. Product: HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System. Reason: Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-01-21
Terminated: 2015-06-01
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K093217 — 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)Intuitive Surgical, Inc.·cleared 2010-01-21

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

HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System

Reason for recall

Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.

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