—#188906

Product

Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10, 5-pack, Sterile EO, Rx only, UDI:00886874115978

FDA product code: EOQ — Bronchoscope (Flexible Or Rigid)
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K182188
Affected lot / code info: Affected Lot Number(s): S90200303, S90200622, S90200727, S90200811, S90200820, S90200831 ,S90200909, S90201008, S90201015 ,S90201103, S90201107, S90201125 ,S90201202, S90201204, S90210114 ,S90210211, S90210225, S90210310 ,S90210318, S90210408, S90210414

Why it was recalled

Potential for the sheath tip on the biopsy needle to separate from the sheath shaft.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

On August 6, 2021, Intuitive Surgical issued an "Urgent Medical Device Recall" notice to affected consignees via Fed Ex. In addition to informing consignees about the recall, Intuitive ask consignees to take the following actions: 1. Inform necessary hospital personnel about this issue. 2. Inform affected personnel when the requested actions have been completed. 3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 4. Please retain a copy of this letter and the acknowledgement form for your files. 5. All returned affected product will be assessed and credit will be provided for the quantity returned. Intuitive will provide a follow up notification once unaffected product becomes available. 6. If you need further information or support concerning this Medical Device Notification, please contact your Endoluminal Sales Representative or contact Intuitive Customer Service at the numbers listed below: " North America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com.

Recalling firm

Firm: Intuitive Surgical, Inc.
Address: 1266 Kifer Rd, Bldg 101, Sunnyvale, California 94086-5304

Distribution

Distribution pattern: US: AZ, AR, CA, CO, DC, FL, GA, IL, IN, IO, MD, MA, MI, MN, MO, NV, NJ, NY, NC, OH, OK, PA, TN, TX, UT, VA, WA OUS: China

Timeline

Recall initiated: 2021-08-06
Terminated: 2024-05-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188906. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.