—#133843

Product

EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument.

FDA product code: NAY — System, Surgical, Computer Controlled Instrument
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K140189
Affected lot / code info: PN 480322-04, Lot numbers: S10140730 S10140904 S10141007 S10141103 S10140805 S10140912 S10141009 S10141111 S10140814 S10140916 S10141015 S10141118 S10140824 S10140923 S10141020 S10141125 S10140827 S10141001 S10141028.

Why it was recalled

Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws.

Root cause (FDA determination)

Process control

Action the firm took

Intuitive Surgical sent an Urgent Medical Device Correction letter dated Feruary 11, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: 1. Forward this letter to any members of your medical staff who perform da Vinci procedures in addition to your Risk Manager, OR Director, Purchasing and Biomedical Engineering staff. 2. This field correction does not require you to quarantine or return the affected devices. Vessel Sealers can continue to be used safely by adhering to the following guidelines as provided in the Vessel Sealer User Manual: a. Only procedures that incorporate sealing and transection of thin tissue bundles and small diameter vessels are affected by this issue. Prior to the procedure, determine whether this issue may be a factor and choose whether or not to use the device per the following instructions. Alternative methods of sealing and transection are described below. b. During sealing, always inspect tissue for energy effect (i.e. blanching, steam, bubbling) along the entire jaw of the instrument. While audio tones designate seal cycle completion, tissue effect should always be seen prior to proceeding to cut. If no tissue effect is seen, then DO NOT CUT. Re-grasp tissue and re-attempt sealing as described above. If the issue persists, the instrument may be affected and an alternative means of sealing and transecting thin vascular tissue bundles should be used. These other methods include using another da Vinci Vessel Sealer, alternative da Vinci electrosurgical instruments, a da Vinci Harmonic instrument or hand-held laparoscopic sealing device. 3. Complete the attached Acknowledgement Form and return it to Intuitive Surgical as instructed. 4. Please retain a copy of this letter and the Acknowledgement Form for your files. 5. If you choose to not continue to use affected Vessel Sealer instruments, you may retu

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, China, Denmark, Ecuador, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Timeline

Recall initiated: 2015-02-11
Posted by FDA: 2015-02-24
Terminated: 2015-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133843. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.