—#132749

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

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K093217
Affected lot / code info: PN 400274, 420274, and 420272.

Why it was recalled

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

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 100, Sunnyvale, California 94086-5304

Distribution

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.

Timeline

Recall initiated: 2015-01-21
Posted by FDA: 2015-02-13
Terminated: 2015-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132749. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.