EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The En

FDA device recall Z-1142-2015 · posted 2015-02-24 · Terminated

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

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.

Action taken

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

Root cause

Process control

Status

Terminated

Product code

NAY

Quantity affected

3282 - total both part numbers

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, China, Denmark, Ecuador, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Puerto Rico, Saudi Arabia, S

Date initiated

2015-02-11

Date posted

2015-02-24

Date terminated

2015-06-01

Location

Sunnyvale, CA

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