ACTION REQUIRED
Contents
1. C1018 FC1019 9033G0601 9033G0801 9033G0701 9033G0702 9033G0711 9033G0712 9033G07132. December 31 2008 FHC Microelectrodes and Instrumentation for Neuroscience Research and Clinical microTargeting MEDICAL DEVICE CORRECTION FHC Inc and Medtronic microTargeting W Drive System and Drive System Accessories Motor Encoder ACTION REQUIRED Please ensure this notice is forwarded immediately to all users of the above models Dear Healthcare Provider FHC is writing to inform you of a potential concern affecting a component of your FHC microTargeting Drive System the Array Insertion Tubes FHC has received six reports over the last four years regarding insertion tube performance issues Although no patients have been injured by such a product failure and no single root cause has been identified we believe the potential risks are serious enough to give this concern emphasis FHC has amended the warnings related to the pre use inspection of the insertion tubes Insertion tubes are extremely delicate and can be damaged during shipping and handling Just as one inspects the microelectrode tips and contacts before use so too should one ensure that the tubes are straight and fully intact FHC will be adding the following recommendations to our microTargeting Drive Directions for Use or User Manual N Warning As the most critical component of a procedure delicate insertion tubes should always be carefully inspected before use because damage to them can cause targeting errors and impact patient safety Handle inse
3. MERS TAKE THE FOLLOWING ACTIONS 1 Please include this Notification in your current User Manual for easy reference 2 To acknowledge receipt of this communication and to ensure prompt delivery of the revised Directions for Use please contact us via Website log in www fh co com mT08RSP Email address quality fh co com Or complete the box below and transmit via facsimile to Fax 1 207 666 8309 If you have any questions concerning this notification you may contact Keri Seitz Senior Regulatory Affairs Associate at 1 207 666 8190 x2210 or 1 800 326 2905 US and Canada We appreciate your attention to this notification Our goal is to provide our system users with the most current and helpful information possible We thank you in advance for ensuring that this document is reviewed by all system users and for your timely response Sincerely Fred Haer President Please send the revised Direction for Use to Name Department Institution Street Address City State Country Postal Code Email Phone IMPORTANT Please complete this page and fax to 1 207 666 8309 This acknowledges your receipt of this notice and ensures prompt delivery of the new microTargeting Drive System Directions for Use Innovation through collaboration L012 08 02 01 XXX microTargeting microTargeting Drive System Directions for Use New Warning amp Caution Statements New Warnings N As the most critical component
4. e cover is provided to protect the opening in the top of the microTargeting TM Drive when an accessory is not attached Failure to use the cover could allow debris to enter the drive mechanism The cover should be removed during cleaning and sterilization to allow proper drainage from this mechanism CAUTION Never turn the manual advancement knob on the microTargeting Drive while a motor is engaged This can damage both the motor and the drive CAUTION The accessory components should be inspected visually prior to each use for physical damage frayed or kinked cables or damaged connectors CAUTION Do not zero the Display Unit until prompted Failure to do so will result in display errors FHC Inc 1201 Main Street Bowdoin ME 04287 7302 USA Fax 724 588 1273 E mail fhcinc fh co com www fh co com 24 hour Technical Service 1 800 326 2905 US amp Can Tel 207 666 8190 FHC Europe TERMOBIT Prod srl 129 Barbu Vacarescu Str Sector 2 Bucharest 020272 Romania Innovation through collaboration LO12 08 XXXX December 31 2008 microTargeting Drive Svstem microTargeting Arrav Insertion Tube w Stvlet Model numbers 66 DA EN 66 DA EN 02 66 DA ME 66 DA ME MOD 66 EL MC 66 EL MS 66 EL MS 01 66 EL MS 02 66 EL MS 03 66 EL MS 04 66 EL PD 66 ZD MD 66 ZD MD 01 MODMT DS AM MT DS MT DS 01 MT DS AM MT DS MD MT PA MT SXSTEM 66 DS PA FC1006 FC1007 FC1008 FC1011 FC1012 F
5. f the microTargeting M Drive This limit may be changed through the serial interface of the microTargeting M Controller However setting the limit above 50mm could result in drive travel beyond the expected target N Do not operate the controller unit in the presence of flammable anesthetics New Cautions CAUTION Unauthorized field repairs may affect calibration and function Units requiring repair should be returned to FHC or an authorized representative for service CAUTION FHC s regulatory clearance requires that microTargeting Drive systems and components be serviced and recalibrated every 100 uses or factory evaluated on an annual basis CAUTION Pre use check should include retracting or advancing the Drive motor using the handheld remote Confirm that the knob can be turned to its clockwise advance and counterclockwise retract limits and when released returns to the center position No movement of the Drive should occur when the remote control knob is in the center resting position If there are any abnormalities perform the calibration procedure FHC Inc 24 hour Technical Service FHC Europe Innovation through collaboration 1201 Main Street 1 800 326 2905 US amp Can TERMOBIT Prod srl Bowdoin ME 04287 7302 USA Tel 207 666 8190 129 Barbu Vacarescu Str Sector 2 Fax 724 588 1273 Bucharest 020272 E mail fhcinc fh co com Romania WWW fh co com L012 08 XXXX December 31 2008 microTargeting CAUTION Th
6. n FHC Inc 24 hour Technical Service FHC Europe 1201 Main Street 1 800 326 2905 US amp Can TERMOBIT Prod srl Bowdoin ME 04287 7302 USA Tel 207 666 8190 129 Barbu Vacarescu Str Sector 2 Fax 724 588 1273 Bucharest 020272 Romania E mail fhcinc fh co com WWW fh co com L012 08 XXXX December 31 2008 microTargeting microTargeting M Drive Accessories Motor Encoder Directions for Use New Warning amp Caution Statements New Warnings N None of the Drive Accessories should be sterilized use the sterile draping system as described In the event of any Drive Accessory failure erratic function or motor stall remove it and proceed using the microTargeting Drive manually N Always confirm that the microTargeting Drive is set at Omm when zeroing the microTargeting M Controller As a safetv feature the Displav Unit cannot be re zeroed without powering off the Module Not doing so will cause the drive limit to be incorrect and also will cause the Controller Displav to be out of svnc with the drive position as read on the drive scale JN During the procedure periodically compare the physical scale depth reading with Controller reading to ensure proper operation If the two scales differ by more than 100 microns discontinue use of the Display Unit and proceed manually N The microTargeting Controller has been factory set to enforce a software drive limit of 50mm which corresponds with the maximum travel o
7. of a procedure delicate insertion tubes should always be carefully inspected before use because damage to them can cause targeting errors and impact patient safety Handle insertion tubes and spacer tubes carefully to prevent bending e Check to be certain that all the insertion tube components are 1 5 secure with the stylet removed grasp the large diameter collar at the proximal end and the smaller distal end and administer a a gentle pull being careful not to bend or twist the tube If there is any movement the insertion tube should not be used al a dk e Check to be certain that tubes are straight with the collar over the edge roll the insertion tube over a flat surface or in the DBS measurement tool slot N Always confirm the tightness of thumbknobs and set screws especially those holding the frame adapter before beginning the procedure The stereotactic adapter must be securelv held in the frame mount so that the drive system cannot move or rotate A Improper cable connections may cause erroneous results including unintended stimulation through metal contacts in the brain N If any error or erratic function is observed discontinue use of the drive immediately and evaluate the potential impact to patient safety before continuing its unmitigated use N While often snug all tubes used with the microTargeting Drive System have been designed to be inserted and removed by hand A tool should be used only as a last resort f
8. or tubes that cannot be removed bv hand use of tools in this manner indicates svstem repair is necessarv N Prior to use the microTargeting Drive System should be completely assembled and correct operation verified to ensure that all components function properly Improper set up of equipment may lead to serious patient injury FHC Inc 1201 Main Street Bowdoin ME 04287 7302 USA Fax 724 588 1273 E mail fhcinc fh co com www fh co com 24 hour Technical Service 1 800 326 2905 US amp Can Tel 207 666 8190 FHC Europe Innovation through collaboration TERMOBIT Prod srl 129 Barbu Vacarescu Str Sector 2 Bucharest 020272 Romania LO12 08 XXXX December 31 2008 microTargeting New Cautions CAUTION The drive svstem and its associated insertion tubes are not MRI compatible CAUTION When tightening set screws use only the tool provided When tightening thumbknobs hand tighten only Over tightening can cause damage to the drive system and adversely affect targeting a CAUTION Do not over tighten these screws as it may damage the microelectrode or DBS electrode See figures a and b CAUTION FHC s regulatory clearance requires that microTargeting Drive systems and components be serviced and recalibrated every 100 uses or factory evaluated on an annual basis CAUTION To ensure proper drainage remove cover during cleaning and sterilization See figure c b Innovation through collaboratio
9. rtion tubes and spacer tubes carefully to prevent bending e Check to be certain that all insertion tube components are secure with the stylet removed grasp the large diameter collar at the proximal end and the smaller distal end and administer a gentle pull being careful 3 not to bend or twist the tube If there is any movement the insertion tube should not be used e Check to be certain that tubes are straight with the collar over the edge roll the insertion tube over a flat surface or in the DBS measurement tool slot In addition to the above noted amendments to the Drive Directions for Use revisions are underway to the Drive and Accessories documents which are a result of our continuous risk assessment and product improvement efforts This notification includes a summary of all new WARNINGS and CAUTIONS as well as those that have been significantly modified The Directions for Use improvements will also include illustrations and photographs for greater clarity as well as a CD of certified translations FHC anticipates having the new Directions for Use ready for release in January 2009 Innovation through collaboration FHC Corporate amp Manufacturing 1201 Main Street Bowdoin ME 04287 7302 USA Tel 207 666 8190 US amp Can 800 326 2905 Fax 207 666 8292 E mail fhcinc fh co com www fh co com FHC Europe TERMOBIT PROD srl 129 Barbu Vacarescu Str Sector 2 Bucharest 020272 Romania FHC IS REQUIRING CUSTO
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