Renessa RF System…

Date posted by the FDA

April 16, 2010

Status

Terminated

Filed by

Novasys Medical Inc

Product

Renessa RF System, model PR0918, manufactured by Novasys Medical, Newark, CA

Reason

Instructions for Use (IFU) revision-- Because of complaints received by the firm of worsened stress incontinence symptoms 3-4 weeks after treatment, the instructions for use were revised to emphasize potential side effects. Although Novasys has not, to date, identified a device malfunction associated with the symptoms discussed above, the investigation over time shows that there is a correlation

Distribution pattern

US nationwide only. (TX, FL, CA, LA, KY, MO, GA,OR WA, HI, AZ, OK AL, TN) .

Quantity

As of 6/12/09 there were 436 Probes at customer accounts.

Codes and lots

Issue affects all lots in distribution.

Recall started

July 27, 2009

Device type

Applicator, Transurethral, Radio Frequency, For Stress Urinary Incontinence In Women

Root cause (FDA)

Labeling design

What the company told customers

A Field Action notification letter was sent to all current customers (physicians) along with the revised instructions for use, and a small supply of the revised patient information brochures. The company also updated physician information brochures and patient/physician DVDs to include the information. This was shipped to physicians in August/September of 2009. Additional copies of the Patient Brochures can be ordered by contacting Novasys Customer Service at 866-784-4777. Questions should be addressed to the firm at the same telephone number.

Recall number

Z-1404-2010

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1404-2010. The agency record governs; check it and the company before acting.