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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
Device Problems Use of Device Problem (1670); Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since a craniotomy apparently was performed not exactly in the intended location, with the brainlab device involved, although: - there is no indication of a systematic error or malfunction of the brainlab device - corresponding measures to minimize this anticipated risk as low as reasonably practicable are already in place - according to the hospital, the enlargement of the craniotomy is not considered a significantly increased risk for this surgery/patient, the tumor was resected successfully, there was no delay of surgery, and there were no adverse effects (other than the craniotomy is bigger) for the patient. 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 craniotomy apparently performed not exactly in the intended location (and display of tumor position not matching its actual position) is a combination of the following factors: - the navigation reference array and/or the patient's head in the head holder might have moved during draping of the patient and exchange from unsterile to sterile array, leading to a deviation of position information displayed by the navigation software. The initial patient registration was not verified after draping of the patient, which would have revealed such a movement of the reference array. - inappropriate quality of the mr patient image that was used for navigation (it was not performed according to the brainlab scan protocol and showed skin shift and motion artefacts) as well as registration point acquisition not being performed in the recommended area (points not collected directly on skin), leading to a patient registration that was not as accurate as desired for this specific patient/surgery. This was apparently not recognized during verification of accuracy after initial patient registration. Further contributing factor (in regard to the observed deviation of displayed tumor position from actual tumor position): - brain shift may have occurred due to the surgical steps (craniotomy) performed and may have led to a decreased navigation accuracy. There is no indication of a systematic error or malfunction of the brainlab navigation device. Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place. Brainlab intends to: - inform this hospital about the investigation results, - corresponding to the root cause, brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.
 
Event Description
A cranial surgery for tumor resection (meningioma, size approx. 38 mm) was performed with the aid of the brainlab cranial 3. 0 navigation software. During the procedures the surgeon: - positioned the patient in supine position, - registered the actual patient anatomy to the navigation (to the pre-operative image imported into and used by the navigation system), - verified and accepted the patient registration in the navigation, - performed the craniotomy with the aid of navigation, - realized (prior to tissue resection) that the tumor is not located where indicated by navigation (deviation of approx. 2 cm), - decided to abandon navigation, - enlarged the craniotomy and resected the tumor. According to the hospital, the enlargement of the craniotomy is not considered a significantly increased risk for this surgery/patient, the tumor was resected successfully, there was no delay of surgery, and there were no adverse effects (other than the craniotomy is bigger) for the patient.
 
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Brand NameCRANIAL NAVIGATION SOFTWARE (VERSION 3.0)
Type of DeviceIMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 85622
GM 85622
Manufacturer (Section G)
BRAINLAB AG
kapellenstrasse 12
feldkirchen, 85622
GM 85622
Manufacturer Contact
andrea miller
kapellenstrasse 12
feldkirchen, 85622
GM   85622
89 9915680
MDR Report Key6198298
MDR Text Key63087455
Report Number8043933-2016-00043
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeSN
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 11/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22216
Device Catalogue Number22216
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 Received11/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2016
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: 12/22/2016 Patient Sequence Number: 1
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