Recall Z-3025-2018
Intuitive Surgical, Inc. · initiated August 15, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
Codes / lots: Model Number 47179-14 Device Listing D215864 UDI Number 00886874112298 Lot Numbers: S11160307 N11171009 N10171010 N10171012 N10180219 N10180214 N10180212 N10180220 N10180221 N10171017 N10180213 N10180215 T10180212 N11180212 T10180208 N10171002 N10170921 N10171023 N10171018 N10170819 N10170818 N10170911 N10170807 N10170808 N10170914 N10171016 N10170718 N10171019 N10171005 N10171009 N10171004 N10171003 N11170911 N10170927 N10170926 N10170815 N11170922 N11170912 N10170809 N10170814 N10170925 N10170922 N10170728 N10170713 N10170912 N10170614 N10170906 N10170824 N10170703 N10170816 N10170811 T10170720 N10170727 N10170724 N10170712 N10170803 N10170721 N10170802 N10170602 N10170720 N10170620 N10170719 N10170801 N10170714 N10170619 N10170711 S10170525 N10170626 N10170613 N11170513 N10170706 N11170223 N10170531 N10170628 N10170612 N10170629 S10170705 S10170523 N10170616 N10170605 N10170615 N10170307 N10170622 N10170518 N10170609 N10170607 N10170504 N10170606 N11161213 N10160831 N10170317 N10170418 N10170601 N10170526 N10170405 N10170511 N10170524 N10170522 N10170508 N10170519 N10170513 N10170515 N11170306 N10170509 N10170516 N10170428 N12170223 S10170501 S10170223 N11170429 N10170427…
Reason for recall
Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.
FDA-determined cause: Use error
Action taken
On August 15, 2018, the firm sent an Urgent Medical Device Notification to customers via Federal Express overnight service informing them that certain lots of monopolar curved scissors may be more susceptible to developing cracks near the proximal edge of the extension tube that may cause fragments of the extension tube to fall, including potentially into patients. Customers were advised of the following 1) Always inspect the instruments prior to use for any damage; 2) Use of an instrument for a task other than the instruments designed use may result in breakage or damage; 3) During reprocessing, make certain that the MCS has been adequately rinsed and flushed, and all cleaning chemicals have been removed. Customers were instructed to read and complete actions on the firms website or to fill out and return Acknowledgement Forms to the firm. Customers with questions are encouraged to call Customer Service: - North and South America: 800-876-1310 Option 3 (4 am to 5 pm PST) - Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) - South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) - Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) Field Corrective Actions: All customers who received a-16 version of S/Si MCS instrument and the -14 version of X/Xi MCS instrument will receive a customer letter, as a notification of the issue and to reiterate guidelines for proper inspection and use of the MCS instrument. Preventive Actions: The -16 version of S/Si MCS instrument and the -14 version of X/Xi MCS instruments are no longer being shipped to customers. A new design has been introduced to prevent the extension tube from being susceptible to cracking. This new material in has been shown to be robust to environmental stress cracking.
Details
- Recall number
- Z-3025-2018
- Initiated
- August 15, 2018
- Product code
- NAY – System, Surgical, Computer Controlled Instrument
- Quantity
- 42,274 (X/Xi)
- Distribution
- Worldwide Distribution - US Nationwide in the states of : AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MA, ME, MD, MI, MN, MS, MO, NB, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WI, and WY and the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland…
- Recalling firm
- Intuitive Surgical, Inc., Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3024-2018 Class II | da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage:…Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of… | 08/15/2018Open, Classified |