Field Safet Notice / Product Notification
Contents
1. F BRAINLAB coat Da KapellenstraBe 12 85622 Feldkirchen Germany phone 49 89 99 1568 O fax 49 89 99 15 68 33 FIELD SAFETY NOTICE PRODUCT NOTIFICATION Subject Cranial Navigation System Standard Cranial Reference Array For specific combinations an inaccuracy of more than 1mm might be added to the registration result when exchanging Standard Cranial Reference Arrays www brainlab com Product Reference Standard Cranial Reference Array Date of Notification Aug 3 2012 Individual Notifying Julia Mehltretter MDR amp Vigilance Manager Brainlab Identifier 11 12 22 TGE 2 Type of action Device component exchange advice regarding use of device We are writing to advise you of the following effect Brainlab has internally determined for specific combinations of Standard Cranial Reference Arrays when used for the exchange of unsterile with sterile array in conjunction with the Brainlab Cranial Navigation System This Notification letter is to provide you with corrective action information and to inform you of the actions Brainlab is taking to address this issue Effect Manufacturing tolerances of the Standard Cranial Reference Array influence the actual position of its marker spheres The differences between the individual arrays are supposed to be very small not significantly affecting navigation accuracy when the unsterile array is exchanged with the sterile array during surgery However there are specific pairs2. and thank you in advance for your co operation If you require further clarification please feel free to contact your local Brainlab Customer Support Representative Customer Hotline 49 89 99 15 68 44 or 1 800 597 5911 for US customers or by E mail support brainlab com Fax Brainlab AG 49 89 99 15 68 33 Address Brainlab AG headquarters Kapellenstrasse 12 85622 Feldkirchen Germany Aug 3 2012 Kind Regards ne Julia Mehltretter MDR amp Vigilance Manager brainlab vigilance brainlab com Europe The undersign confirms that this notice has been notified to the appropriate Regulatory Agency in Europe Attachments Appendix A List of affected serial numbers for article 41735 Appendix B List of affected serial numbers for article 41730A FORM 14 04 11 12 22 TGE 2 Rev 7 Page 3 of 5 BRAINLAB Appendix A List of affected serial numbers for article 41735 Article 41735 STANDARD CRANIAL REFERENCE ARRAY O wo O ero Eo www brainlab com FORM 14 04 11 12 22 TGE 2 Rev 7 Page 4 of 5 BRAINLAB Appendix B List of affected serial numbers for article 41730A Article 41730A REFERENCE CLAMP UNIVERSAL WITH 2 ARRAYS www brainlab com FORM 14 04 11 12 22 TGE 2 Rev 7 Page 5 of 5
3. ay With this exchange an inaccuracy of more than 1 mm might be added to the registration result if array pairs with specific combinations of tolerance limits are used User Corrective Action According to our records you are the owner of one or several of the potentially affected Standard Cranial Reference Arrays Therefore please check your Standard Cranial Reference Arrays and do not use reference arrays with one of the serial numbers listed in Appendix A and B Please note that for article 41730A REFERENCE CLAMP UNIVERSAL WITH 2 ARRAYS two reference arrays bear the same serial number In this case both reference arrays must no longer be used Please remove the according reference arrays from clinical use You will be provided with a replacement accordingly Where you can find the serial number Serial number Article number Figure 2 Where to find the Serial Number on the Standard Cranial Reference Array FORM 14 04 11 12 22 TGE 2 Rev 7 Page 2 of 5 BRAINLAB In any case please continue to follow the instructions in the relevant user manuals e The Brainlab Cranial ENT instruments are highly accurate and sensitive medical devices and must be handled with extreme care If you drop or otherwise damage an instrument return it immediately to Brainlab for testing Failure to do so may lead to serious injury to the patient e Do not use damaged instruments e Do not change the position of the headholder adapter whe
4. n attaching the sterile reference array This could result in inaccurate tracking and severe patient injury www brainlab com e Verify registration accuracy after exchanging the unsterile reference array for the sterile reference array e Do not move a reference array relative to the patient s anatomy during the procedure Changing the array s position throws off the entire measurement coordinate system endangering the patient e To avoid unintentional movement of the reference array do not place pressure on it e lf the position of the reference array changes relative to the patient a new registration is required e Anewregistration is required if the patient was repositioned after registration e Check regularly that the marker spheres remain tightly screwed onto the pins e Navigation accuracy critically depends on the condition of the marker spheres used e Verify prior to use that the reflective surface of all marker spheres is in good condition and not peeling Brainlab Corrective Action 1 Existing potentially affected customers who own one or several of the potentially affected Standard Cranial Reference Arrays receive this product notification letter 2 Brainlab will actively provide revised hardware to improve exchange compatibility to these customers as of October 2012 Please advise the appropriate personnel working in your department of the content of this letter We sincerely apologize for any inconvenience
5. of arrays that might add an inaccuracy of more than 1mm to the registration result during the exchange due to the combination of their tolerance limits The Appendix lists the potentially affected arrays identified by Brainlab simulations This effect could potentially cause an inaccurate display of instruments by the navigation system in the region of interest compared to the actual patient anatomy If these inaccuracies are not detected by user verification of navigation accuracy as described in the user manual this could lead to serious injury or ineffective treatment of the patient Figure1 Standard Cranial Reference Array FORM 14 04 11 12 22 TGE 2 Rev 7 Page 1of5 BRAINLAB Details Reference arrays e g the Standard Cranial Reference Array allow the navigation system to track the location of the patient s anatomy throughout the procedure Usually two reference arrays are used e One for preoperative procedures patient registration The reference array used for registration may be unsterile as registration is usually performed in an unsterile envi www brainlab com ronment e One for intraoperative navigation The reference array used for navigation must be sterilized before use and attached during draping After the successful registration of the patient using the Brainlab navigation software it is required to carefully remove the unsterile reference array drape the patient and then attach the sterile reference arr
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