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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

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BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.1) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 22216-02C
Device Problems Use of Device Problem (1670); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2021
Event Type  Injury  
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since a craniotomy deviated from the desired location (and needed to be extended/corrected for surgery to be effective as intended), with the brainlab device involved, despite according to the surgeon there was no negative clinical effect to the patient, nor did the hospital/surgeon report any medical/surgical remedial action that would have been necessary, done or planned for this patient due to this issue. 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 to the fda upon completion of investigation.
 
Event Description
A cranial surgery for a resection of a cerebellar tumor has been performed with the aid of the brainlab navigation software cranial 4. 0. During the surgery, the patient was positioned prone and the neurosurgery registrar performed the registration of navigation to the preoperative scan using fiducials. The registrar planned the craniotomy using the aid of the display of navigation, and removed the bone flap. According to the surgeon, the location of the craniotomy was not in the intended location. The surgeon alleged that an inaccuracy in the display of navigation caused or contributed to the incorrect location of the craniotomy. The surgeon proceeded with the surgery by slightly 'refashioning' the craniotomy, with the size of the correction/enlargement deemed to be minimal, according to the surgeon. The surgeon completed the surgery successfully, using conventional methods and without the use of navigation. According to the surgeon, there was no actual harm or negative clinical effect to the patient due to this issue, although the surgeon stated there was an increased risk of harm due to the proximity of the location of the craniotomy to the sinus. There has been no report of any (further) medical/surgical remedial action that would have been necessary, done or planned for the patient due to this issue.
 
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Brand NameCRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
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 Key12016353
MDR Text Key256715389
Report Number8043933-2021-00045
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K192703
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22216-02C
Device Catalogue Number22216-02C
Device Lot NumberSW V. 3.1.5
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 Received05/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2020
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: 06/17/2021 Patient Sequence Number: 1
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