Recall Z-0448-2015
Intuitive Surgical, Inc. · initiated November 3, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
Codes / lots: Part number; 470347-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.
Reason for recall
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.
FDA-determined cause: Labeling design
Action taken
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.
Details
- Recall number
- Z-0448-2015
- Initiated
- November 3, 2014
- Posted by FDA
- November 25, 2014
- Terminated
- February 3, 2015
- Product code
- NAY – System, Surgical, Computer Controlled Instrument
- Quantity
- 509 total units, all affected devices.
- Distribution
- US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.
- Recalling firm
- Intuitive Surgical, Inc., Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0427-2015 Class II | 8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical…Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface… | 11/03/2014Terminated |
| Z-0428-2015 Class II | 8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface… | 11/03/2014Terminated |
| Z-0429-2015 Class II | 8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0430-2015 Class II | 8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0431-2015 Class II | 8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0432-2015 Class II | 8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0433-2015 Class II | 8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0434-2015 Class II | 8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0435-2015 Class II | 8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0436-2015 Class II | 8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0437-2015 Class II | 8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0438-2015 Class II | 8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0439-2015 Class II | 8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0440-2015 Class II | 8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0441-2015 Class II | 8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of… | 11/03/2014Terminated |
| Z-0442-2015 Class II | 8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0443-2015 Class II | 8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0444-2015 Class II | 8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0445-2015 Class II | 8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0446-2015 Class II | 8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0447-2015 Class II | 8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |