—#131233

Product

8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K131861
Affected lot / code info: Part number 470205-05; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Why it was recalled

Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Root cause (FDA determination)

Labeling design

Action the firm took

Urgent Medical Device Recall letters were sent to affected sites on November 3, 2014. Letters inform customers of the reason for recall, risk to health and the affected instrument. A table of all of the affected IS4000 instruments affected is attached to the letter indicating the part number and product name for each. Letters also inform customers that all instruments shipped since July 2014 are manufactured with a new material and not subject to recall. Customers are to take the following actions: 1. Ensure that all affected personnel are aware of the information. 2. Identify affected product in their possession 3. Contact ISI rep for replacement. 4. Complete and return the attached Acknowledgement From. Until replacement instruments are received, the old instruments may be used provided they do not show signs of degradation and that the reprocessing instructions are followed. Questions to 800-876-1310 Option 3 ( 6 am to 5 pm PST) or ics@intusurg.com.

Recalling firm

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

Distribution

Distribution pattern: US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.

Timeline

Recall initiated: 2014-11-03
Posted by FDA: 2014-11-25
Terminated: 2015-02-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #131233. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.