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U.S. Department of Health and Human Services

Class 2 Device Recall EndoWrist One Vessel Sealer, IS3000

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  Class 2 Device Recall EndoWrist One Vessel Sealer, IS3000 see related information
Date Initiated by Firm February 11, 2015
Date Posted February 24, 2015
Recall Status1 Terminated 3 on June 01, 2015
Recall Number Z-1141-2015
Recall Event ID 70467
510(K)Number K110639  
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci Surgical System Si IS3000
The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for bipolar coagulation and mechanical transection of vessels up to 7mm in diameter and tissue bundles that fit the jaws of the
instrument.
PN 410322-05
Code Information PN 410322-05Serial numbers: M10140807 M10140926 M10141028 M10141119 M11140917 M11141119 M10140812 M10141001 M10141029 M10141125 M11140922 M11141125 M10140814 M10141004 M10141031 M10141126 M11140926 M11141126 M10140818 M10141006 M10141104 M10141128 M11141001 M11141201 M10140826 M10141009 M10141105 M10141201 M11141004 M10140828 M10141015 M10141107 M11140808 M11141006 M10140902 M10141020 M10141111 M11140818 M11141009 M10140905 M10141022 M10141113 M11140826 M11141015 M10140917 M10141023 M10141114 M11140828 M11141020 M10140922 M10141024 M10141117 M11140904 M11141024
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Mark Johnson
408-523-2100
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action 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
Quantity in Commerce 3282 total units, all 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, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NAY and Original Applicant = INTUITIVE SURGICAL, INC.
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