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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.1) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

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BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.1) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 22214A
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/23/2017
Event Type  malfunction  
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since electrodes were placed in locations in the patient's brain different than planned with the brainlab navigation device involved, despite according to the surgeon: - the results of the surgery were still in accordance with expectation. - there were no negative effects to the patient, neither due to electrode placements nor due to prolong of surgery/anesthesia (of ca. 1. 5 hrs. ). - there are no remedial actions necessary, done or planned for this patient due to this issue. According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause for the deviations of the actual positions of the electrodes from the planned positions is a suboptimal patient registration for navigation, that was apparently not detected by the user with the necessary verification of navigation accuracy. Further contributing factors: - the navigation ir camera was placed outside the recommended distance to the reference array (placed too close). - one of the hospital's reference array for navigation has a bent pin, that might contribute to a deviation. It cannot be excluded that this reference array was used at this surgery. There is no indication of a systematic error or malfunction of the brainlab device (navigation). Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place. Brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.
 
Event Description
A cranial surgery for a implantation of 8 seeg electrodes (to treat epilepsy) into the infant patient's brain, has been performed with the aid of the virtual display of the brainlab navigation version 2. 1. 1. Pre-operative ct scans were acquired ca. 2. 5 weeks before the surgery, to use with navigation. Trajectories for the electrodes were planned on the pre-op ct scans and mri scans before the surgery with the brainlab iplan planning sw. During the procedure the surgeon: - positioned the patient in a prone orientation in a (non-brainlab) head holder. - performed the initial patient registration on the pre-op ct with surface matching to match the virtual display of the navigation to the current patient anatomy. Several attempts were necessary to achieve a desired registration accuracy. - draped the patient, verified the accuracy of the registration and determined the result as very good. - created the burr holes, and placed the 8 electrodes with aid of navigation. A post-op ct scan was performed, and the surgeon determined that the electrode locations differed by ca. 2 mm to ca. 7 mm from the intended target locations. According to the surgeon: - the results of the surgery were still in accordance with expectation. - there were no negative effects to the patient, neither due to electrode placements nor due to prolong of surgery/anesthesia (of ca. 1. 5 hrs. ). - there are no remedial actions necessary, done or planned for this patient due to this issue.
 
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Brand NameCRANIAL NAVIGATION SOFTWARE (VERSION 2.1.1)
Type of DeviceIMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
BRAINLAB AG
olof-palme-strasse 9
münchen, 81829
GM 81829
Manufacturer (Section G)
BRAINLAB AG
olof-palme-strasse 9
münchen, 81829
GM 81829
Manufacturer Contact
markus hofmann
olof-palme-strasse 9
münchen, 81829
GM   81829
89 9915680
MDR Report Key6348666
MDR Text Key68223315
Report Number8043933-2017-00007
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K092467
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/24/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22214A
Device Catalogue Number71093
Device Lot NumberSW V. 2.1.1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/22/2017 Patient Sequence Number: 1
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