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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.0) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

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BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.0) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 22216-01
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2020
Event Type  Injury  
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since an instrument path was applied in a different location in the brain than intended with the brainlab device involved, despite according to the hospital: a diagnostic sample was retrieved in a revision surgery performed on jun 23, 2020 (the same burr hole was used). There was no (direct or increased) risk to harm a critical structure due to the deviation in the initial surgery. There was no harm/negative clinical effect to this patient due to the deviation in the initial surgery (and also not due to repeat of anesthesia/surgery for 1 hour for the revision surgery). According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the main root cause for the deviation between the applied instrument path from the planned trajectory (approx. 3 mm deviation in target point) is a combination of the following main factors: a bent pin detected on the varioguide array used during this procedure, which could lead to a deviation of displayed instrument position information. Less than ideal point acquisition by the user for patient registration with insufficient points acquired on the patient's left side/region of interest in combination with a poor quality mri scan that was used to register the patient for navigation, specifically significant skin shift in the scan (likely due to restraints) that could have negatively affected the accuracy of the registration result that was accepted for use with navigation. Apparently the resulting deviation of the navigation display was not detected by the user before performing invasive surgical steps, with the necessary continued user verification of accuracy after draping and throughout the surgery not sufficiently performed. 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. The affected varioguide array was removed from clinical use.
 
Event Description
A cranial surgery (on (b)(6) 2020) for biopsy (to retrieve a diagnostic sample), with approximated tumor volume of 7. 5 cm³, located approx. 6 cm in depth, was performed with the aid of the brainlab navigation software cranial 3. 0. A pre-operative mri scan was acquired 13 days before the surgery (on (b)(6) 2020), to use with navigation. During the procedure the surgeon: positioned the patient in supine orientation in a non-brainlab head holder and attached the unsterile 4-sphere standard reference array. Planned a trajectory. Performed the initial patient registration on the pre-operative mri (surface matching without pre-registration points) using the z-touch, to match the display of the navigation to the current patient anatomy. Adjusted the reference array, performed a 2nd patient registration, and accepted the result after verification of registration accuracy. Aligned the varioguide to the planned trajectory and made the burr hole. - modified the entry point of the planned trajectory to match the exact location of the burr hole. Realigned the varioguide to the adjusted trajectory. Took 3 samples using the brainlab-distributed biopsy needle and ended surgery. According to the hospital/neurosurgeon: no diagnostic sample was retrieved in this surgery (note, this biopsy surgery was solely intended to retrieve a diagnostic sample, but not to treat the disease). A diagnostic sample was retrieved in a revision surgery performed on (b)(6) 2020 without aid of brainlab nav. Sw (the same burr hole was used). Hospitalization was prolonged to perform the revision surgery. There was no (direct or increased) risk to harm a critical structure due to the deviation in the initial surgery. There was no harm/negative clinical effect to this patient due to the deviation in the initial surgery (and also not due to repeat of anesthesia/surgery for 1 hour for the revision surgery).
 
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Brand NameCRANIAL NAVIGATION SOFTWARE (VERSION 3.0)
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
andrea miller
olof-palme-strasse 9
münchen, 81829
GM   81829
MDR Report Key10301320
MDR Text Key204402264
Report Number8043933-2020-00037
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04056481138790
UDI-Public04056481138790
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K092467
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22216-01
Device Catalogue Number22216-01
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 Received06/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/20/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/21/2020 Patient Sequence Number: 1
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