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Terminated

HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. 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

FDA Recall Z-1118-2015 · Posted 2015-02-13

Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2015-01-21
Date Terminated2015-06-01
Product Quantity12,467 - both sizes

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.

Firm Action

A Field Safety Notice entitled, Urgent Medical Device Correction, and dated, January 21, 2015, were sent to customers. The letter identified the problem and the reason for the recall as well as the risk to health. Customers are asked to ensure that all affected personnel are informed of the notice. Additionally, customers are to discard their current Harmonic Ace IFUs. Customers are to refer to the specified manual, reference guide, and instruction card mentioned in the letter. A copy of the notice is to be retained with the da Vinci Standard, S or Si user manual. Intuitive Surgical will remove the Harmonic ACE IFU from all future shipments of the product. Representatives will be available by phone to answer questions related to the Correction.

Root Cause

Error in labeling

Distribution Pattern

Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, India, Israel, Italy, Japan, Lebanon, Mexico, Monaco, Netherlands, Pakistan, Panama, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0932175 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM)Intuitive Surgical, Inc. · 2010-01-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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