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Model Number 22216-02C
Device Problems Use of Device Problem (1670); Insufficient Information (3190)
Patient Problems Muscle Weakness (1967); Nerve Damage (1979)
Event Date 03/15/2021
Event Type  Injury  
Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since biopsies and an litt catheter placement were performed in another location in the brain than intended and there was a negative effect for the patient, with the brainlab device involved, according to the surgeon: although the outcome of the surgery was successful, as the litt procedure was the main goal of the surgery and the catheter ablation covered the intended region of interest, despite the biopsy samples were non-diagnostic. Although hospitalization was not prolonged and there are no other remedial actions necessary, done, or planned for the patient. The patient presented negative symptoms after the surgery: the patient had a facial weakness, which the surgeon has stated is reversible. According to the surgeon, this was due to the damage to the patient's facial nerves, which he stated was primarily caused by the problem of the drill stop of the non-brainlab drill guide leading to deeper drilling than intended, but also the unintended trajectory inferior to the lesion (trajectory determined using the aid of brainlab navigation) additionally contributed. 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 diagnostic biopsy and laser interstitial thermal therapy (litt) of a lesion in the right side of the brain near the brainstem, at a depth of 46mm and with a diameter of 20mm was performed with the aid of brainlab navigation software cranial 3. 1. A preoperative mri scan was acquired approx. Two months prior to the surgery to use with navigation. During the procedure the surgeon: planned a trajectory in the navigation software on the preoperative mri. Positioned the patient supine in a non-brainlab head-holder, and attached the brainlab reference array. Performed an intraoperative ct scan and verified and accepted the automatic registration of the current patient anatomy to the navigation (to the intraoperative ct scan imported into and used by the navigation). Performed an image fusion of the intraoperative ct and preoperative mri; the initial fusion was not satisfactory so the surgeon adjusted it manually until he was satisfied, acknowledging that the region of the tumor looked changed slightly since the preoperative mri from two months prior. Ultimately he decided the fusion looked appropriate although acknowledging it could be better, and accepted it to proceed. Verified the accuracy of navigation once more using the ct and mri, and marked the entry point for the biopsy on the patient's skin. Removed the unsterile reference array, draped the patient, and attached the sterile reference array. The surgeon verified the accuracy of navigation again. Aligned the varioguide to the preplanned trajectory, and used the brainlab-distributed navigated biopsy needle to collect samples at the target location. After collecting the samples, the surgeon removed the varioguide. The tissue samples were later determined by pathology to be non-diagnostic tissue. The surgeon reattached the varioguide and verified accuracy at the region of entry. It is not currently known whether a new trajectory was planned, but the surgeon decided to drill a new burr hole for the second biopsy attempt. The surgeon used a non-brainlab drill guide tube and bit to drill a new burr hole for the biopsy; he had some difficulty with the drill skiving due to the angle of the trajectory on the skull. The navigated biopsy needle was used to collect samples at the target region, which were sent to pathology. The surgeon placed a non-brainlab bolt down the navigated trajectory to be used for later placement of the litt catheter. This was the only step of the litt procedure for which brainlab navigation was used. During the litt procedure, the surgical resident had difficulty with the drill stop on the non-brainlab drill guide and plunged it too deep, causing damage to the patient's facial nerves. The surgeon also determined via postoperative mri that the trajectory of the litt catheter (the trajectory determined using navigation) was several millimeters inferior to the lesion, which he said was an additional (although not the primary) contributing factor to the facial nerve damage. According to the surgeon: all biopsy samples ultimately yielded non-diagnostic tissue, but the overall procedure was considered successful, as the surgeon was able to manipulate the ablation to cover the whole lesion during the litt procedure, which was the main goal of the surgery. The patient presented with a facial weakness after the surgery due to the facial nerve damage, which the surgeon has stated is reversible. There was no prolongation of hospitalization. There are no other remedial actions necessary, done, or planned for the patient at this time.
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Manufacturer (Section D)
olof-palme-strasse 9
muenchen, 81829
GM 81829
Manufacturer (Section G)
olof-palme-strasse 9
muenchen, 81829
GM 81829
Manufacturer Contact
maura boyle
olof-palme-strasse 9
muenchen, 81829
GM   81829
MDR Report Key11664377
MDR Text Key245361175
Report Number8043933-2021-00029
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number22216-02C
Device Catalogue Number71201A
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 Received03/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2016
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: 04/14/2021 Patient Sequence Number: 1