Medical device manufacturer, Brainlab AG, has issued a medical device notification concerning its Curve and Kick Navigation Systems. The affected devices are identified as the following:
- CURVE 1.1 DUAL NAVIGATION STATION
- Serial Number of Affected NDI camera installed: P7-21527
- Serial Number of Affected Navigation System: 3911619001-19901
- CURVE 1.2 DUAL NAVIGATION STATION
- Serial Number of Affected NDI camera installed: P7-21173, P7-21183, P7-21325, P7-21324, P7-21382, P7-21414, P7-21830, P7-21892, P7-20390
- Serial Number of Affected Navigation System: 1173019001-19901B, 1444519001-19901B, 1937319001-19901B, 2201419001-19901B, 2456219001-19901B, 3524219001-19901B, 5379420001-19901B, 5609520001-19901B, 6968320001-19901B
- CURVE DUAL DISPLAY NAVIGATION STATION
- Serial Number of Affected NDI camera installed: P7-21890, P7-21780, P7-07290
- Serial Number of Affected Navigation System: 0824912001-19900, 3894613001-19900, 4387415001-19900
- CURVE SINGLE DISPLAY NAVIGATION STATION
- Serial Number of Affected NDI camera installed: P7-10719
- Serial Number of Affected Navigation System: 5762713001-19905
- KICK 2 NAVIGATION STATION
- Serial Number of Affected NDI camera installed: P7-12520, P7-20938, P7-21378, P7-18830, P7-15162, P7-16025, P7-13227
- Serial Number of Affected Navigation System: 0164217001-18170, 2703119001-18170, 2933119001-18170, 6171619001-18170, 8745417001-18170, 9178819001-18170, 9607118001-18170
- KICK NAVIGATION STATION
- Serial Number of Affected NDI camera installed: P7-06110
- Serial Number of Affected Navigation System: 1190017001-18070
According to the manufacturer, some navigation cameras installed on specific Brainlab Curve and Kick Navigation systems were delivered with an incorrect manufacturer calibration, resulting in combination with the Z-touch Laser Pointer in a registration shift of about 6mm that becomes obvious during the necessary adequate registration validation. As another side effect of the same camera manufacturing defect, the communication with the Softouch Pointer and with the optional Disposable Clip-On Remote Control does not work. The navigation camera calibration error affects specific camera serial numbers only. Passive marker detection, e.g. with the Disposable Reflective Marker Spheres, is not affected. There has been no negative effect on a patient reported to the manufacturer by any user due to this issue. (For details, please refer to the manufacturer's FSN)
Affected users are instructed to take the following actions:
- For Cranial or ENT navigation software in combination with an affected system camera installed:
- Do not use the Z-touch Laser Pointer for patient registration. Use other instruments with the standard instrument pivoting method for Surface Matching or Landmark Registration, or Automatic Image Registration (AIR) if available.
- Affected users should continue to follow the instructions and warnings as described in the user guide. Especially relevant is the following warning, in addition to the instructions on the registration verification page appearing in the Cranial or ENT software:
- Verify accuracy at multiple anatomical landmarks, especially in the region of interest, as it may differ from the accuracy verified on the skin surface. If the region of interest is not accessible, verify in areas as close as possible to the region of interest.
- In order to avoid nuisance with Spine & Trauma 3D or Orthopedic Navigation software in combination with an affected system camera installed: Do not attempt to use the optional Disposable Clip-On Remote Control. For patient registration, acquire registration points with the standard instrument pivoting method; or for Spine & Trauma 3D use Automatic Image Registration (AIR) if available.
The manufacturer will exchange the affected specific cameras installed on a Brainlab Curve or Kick Navigation System, to a camera functioning as specified. The manufacturer will actively contact affected users starting mid of September 2020 to schedule the exchange.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 July 2020