Field Safety Notice Urgent Medical Device Correction - 2955842
Contents
1. da Vinci Si Single Site User Manual Actions to be taken by Intuitive Surgical Intuitive Surgical will update documentation via an addendum to the user manual and complete an analysis of the product design Intuitive Surgical representatives will be available by phone to answer any questions related to this Medical Device Correction Further Information amp Support If you need further information or support concerning this issue please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below North and South America 800 876 1310 Option 3 6 AM to 5 PM PST or mail customersupport servicesupport intusurg com Europe Middle East Asia and Africa 800 0821 2020 or 41 21 821 2020 8 AM to 6 PM CET or ics intusurg com South Korea 02 3271 3200 9 AM to 6 PM KSTJ Please be informed that the appropriate Regulatory Authority for your region has been notified Sincerely Intuitive Surgical 950 Kifer Road Sunnyvale CA 94086 5304 USA 800 876 1310 September 3 2015 PN 552180 01 Rev B 2955842 08 08 15 008 C Page 4 of 6 Position Robotics Coordinator Operating Room Director Risk Manager Surgeon Other ________________ ACKNOWLEDGEMENT FORM Field Safety Notice Urgent Medical Device Correction 2955842 08 08 15 008 C da Vinci Si Single Site Grip Release Hospital Name Address City Postal Code NSID AT2. September 3 2015 PN 552180 01 Rev B 2955842 08 08 15 008 C Page 1 of 6 Field Safety Notice Urgent Medical Device Correction 2955842 08 08 15 008 C da Vinci Si Single Site Grip Release Introduction and Reason for Field Action Dear da Vinci Customer The purpose of this Field Safety Notification is to advise you of an issue that could potentially occur involving specific da Vinci Si Single Site gripping instruments Under rare circumstances grip actuated instruments may become fixed in a closed position A list of affected instruments can be found in the Affected Regions and Products section of this letter Figure 1 Single Site gripping instrument example This potential failure has been attributed to excessive force exerted on the instrument during insertion into a curved cannula which may result in 1 A break in the roll gear and or instrument shaft 2 Damage to the push pull mechanism that controls grip opening and closing This potential breakage where the shaft meets the roll gear can occur when excessive force is applied during instrument insertion through the curved cannula The potential break can be in the roll gear only the shaft only or both and can vary from a hairline crack to a complete break between the components The nature of the failure mode is such that it may worsen with continued use the grips may open and close normally following the initial insertion and unexpectedly remain closed la
3. the cannula and the instrument is not enough to hold the instrument firmly with the fingers use forceps or other available surgical tool to aid the process and repeat Step 3 CAUTION Tissue or objects may move as the grips are released 4 Under visualization clear the tissue from the grips If needed adjust the instrument arm to position the instrument away from the tissue Support the instrument arm before clutching to prevent unintended instrument motion 5 After the tissue is cleared from the grips squeeze the release levers on the sides of the instrument housing and pull the instrument out Do not reuse the instrument WARNING Do not reuse an instrument that has had its grip released with the instrument release kit Reusing an instrument after use of the instrument release kit could result in critical failure of the instrument and injury to the patient After manually opening the instrument grips either with the instrument release kit or by following the steps above return the affected instrument to Intuitive Surgical by contacting Customer Service
4. TENTION 1 I have received and read this notice 2 I have ensured all appropriate personnel are fully informed of the contents of this notice 3 I will contact Intuitive Surgical if I have any questions Name print ____________________________________ Signature _______________________________________ Hospital Name __________________________________ Phone Number __________________________________ Email __________________________________________ Date ___________________________________________ PLEASE FAX OR EMAIL THIS ACKNOWLEDGEMENT FORM TO Intuitive Surgical Inc ATTN REGULATORY COMPLIANCE Subject line for email da Vinci Si Single Site Grip Release U S Fax 1 408 716 3040 or Scan and Email isi compliance intusurg com Customer Service North America and South America 800 876 1310 Option 3 6 AM to 5 PM PST 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 or ics intusurg com September 3 2015 PN 552180 01 Rev B 2955842 08 08 15 008 C Page 5 of 6 Attachment 1 Instructions to Manually Open da Vinci Si Single Site Grasping Instrument Grips If the grips cannot be opened from the masters at the Surgeon Console or by using the instrument release kit due to damage to the shaft and or roll gear the grips can be opened manually To manually open the grips 1 Verify that the Emergency Stop button wa
5. ed to contain the push pull mechanism All lots relating to the following part numbers could potentially exhibit this failure Part Numbers and Versions Product Name 428050 12 428050 13 428050 14 Maryland Dissector 428053 12 428053 15 Medium Large Clip Applier 428055 12 428055 13 Cadiere Forceps 428056 12 428056 13 Needle Driver 428058 12 428058 13 Fundus Grasper 428059 12 428059 13 Crocodile Grasper 428080 04 428080 05 Maryland Bipolar Forceps 428088 12 428088 13 Curved Needle Driver 428093 12 428093 13 Fenestrated Bipolar Forceps September 3 2015 PN 552180 01 Rev B 2955842 08 08 15 008 C Page 3 of 6 Actions to be taken by the Customer User Please Take the Following Actions 1 Ensure that all affected personnel are fully informed of this notice Forward this notice to your Risk Manager OR Director Purchasing Manager Biomedical Engineering staff and members of your medical staff who perform da Vinci Si Surgery procedures 2 Replace any instrument that shows signs of damage and contact Intuitive Surgical Customer Service 3 If you encounter an issue where the instrument grips remain closed on tissue and the IRK cannot be used please follow the instructions on Attachment 1 4 Complete and return the attached Acknowledgment Form to Intuitive Surgical using the instructions provided 5 Please retain a copy of this notice as well as the attached instructions with your
6. s pressed and the system is still in a faulted state 2 Verify that the grip release tool is in place in the housing and carefully turn the tool counterclockwise approximately 1 4th turn until it engages and can no longer turn Keep the tool engaged during the following steps Figure 1 Figure 1 Keep the grip release tool engaged while manually opening the grips 3 Under visualization have the patient side assistant grasp the instrument shaft below the break Figure 2A and manually pull the shaft back toward the instrument housing Figure 2B to reduce the gap between the broken components Figure 2C CAUTION Tissue or objects may move as the grips are released Roll Gear A B C Figure 2 A Grasp the instrument shaft below the break B Pull the shaft toward the housing C Reduce the gap between separated component lt XXXX gt lt Date place holder gt PN 552180 01 Rev B 2955842 08 08 15 008 C Page 6 of 6 If the black outer shaft covering or other components inside the housing are blocking the shaft from being pulled back toward the housing a slight twisting motion of the roll gear the tan color piece may help to move the obstruction Figure 3 Roll Gear Figure 3 Twist the roll gear tan color piece while holding the shaft in place Note Twisting the roll gear should only be performed under endoscopic view as the instrument grips may also twist If the space between
7. ter in the case even when using the instrument release kit IRK See Figure 2 for example of the instrument roll gear and shaft break Figure 2 Examples of breaks at the roll gear and instrument shaft junction September 3 2015 PN 552180 01 Rev B 2955842 08 08 15 008 C Page 2 of 6 Risk to Health In the worst case scenario in which a da Vinci Si Single Site instrument grip cannot be released normally or by opening the masters or using the instrument release kit the surgeon may need to excise tissue in order to extract the gripped instrument To mitigate this risk instructions on how to open the grips have been provided in Attachment 1 There has been one reported instance out of 81 413 distinct procedures 0 001 related to da Vinci Si Single Site instrument grips becoming fixed in the closed position while gripping tissue The da Vinci Si Single Site User manual provides guidelines for how to properly handle the da Vinci Si Single Site instruments The instruments will work as intended if users continue to adhere to these guidelines Affected Regions and Products Affected Countries Australia Belgium Brazil Canada Chile China Cyprus Denmark France Germany Greece Israel Italy Monaco Netherlands Panama Romania Saudi Arabia Singapore South Korea Spain Sweden Switzerland Taiwan Turkey United Kingdom and United States Affected Product The following da Vinci Si Single Site instruments have been identifi
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