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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 Image Display Error/Artifact (1304); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 10/30/2018
Event Type  Death  
Manufacturer Narrative
With the currently available information, brainlab can neither exclude nor confirm that the brainlab device or its use caused or contributed to the death of the patient. Currently there is no indication of a systematic error or malfunction of the brainlab device, nor of insufficient measures to minimize this anticipated risk as low as reasonably practicable. A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending. Brainlab plans to issue a follow-up report upon completion of investigation.
 
Event Description
A right frontal burr hole and endoscopic (e. G. Direct visualization) resection of colloid cyst of 3rd ventricle with a stereotactic approach was performed with the aid of brainlab navigation system cranial 3. 0. During the procedure the surgeon: performed an intraoperative ct scan using a non-brainlab ct scanner and accepted the automatic registration of the current patient anatomy to the navigation (to the intra-operative ct scan imported into and used by the navigation). Created a burr hole, and passed a sheath through the burr hole. Used the navigated brainlab pointer during the surgery with the sheath. Used a non-navigated non-brainlab endoscope through this sheath. At some point during the surgery, the surgeon detected a deviation of the display of navigation compared to the patient's anatomy. On (b)(6) 2020 brainlab was informed the patient died following complications, when brainlab received a request from the coroner for a report.
 
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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
muenchen, 81829
GM 81829
Manufacturer (Section G)
BRAINLAB AG
olof-palme-strasse 9
muenchen, 81829
GM 81829
Manufacturer Contact
maura boyle
olof-palme-strasse 9
muenchen, 81829
GM   81829
MDR Report Key9653107
MDR Text Key177166430
Report Number8043933-2020-00007
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K092467
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22216
Device Catalogue Number22216
Device Lot NumberSW V. 3.0
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2014
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: 01/31/2020 Patient Sequence Number: 1
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