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

Model Number 22216A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Despite according to the surgeon: a post-operative mri scan confirmed that the trajectory path of the biopsies was correct as intended, and that the unsuccessful biopsy samples were taken in the correct path, but 20mm before the intended target (corresponding to the "tool tip offset" used); there were no negative clinical effects to this patient due to this issue / biopsy resection at this surgery; there was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue) due to the biopsy at location different than desired; there was also no negative effect to the patient due to anesthesia prolong (at this surgery of ca.20min prolong); there are no other remedial actions necessary, done or planned for this patient due to this issue other than additional biopsy apply at same surgery to retrieve desired samples; the surgery was completed successfully as intended with desired samples retrieved at same surgery.A risk to the patient's health could not be excluded for these specific circumstances, since biopsy samples were taken in a different location in the brain than intended (although within the correct path), with the brainlab device involved.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 location of biopsy different than intended is a misinterpretation of the information displayed by the navigation: the tool tip offset selected and displayed was navigated to the target, instead of the needle tip.There is no indication of a malfunction or systematic error of the brainlab device, the brainlab device (navigation) works as specified; corresponding measures for the brainlab device (navigation) to minimize this anticipated risk as low as reasonably practicable are already in place.Brainlab intends to re-iterate to this customer: the display functions available in the navigation for the "tool tip offset" function, and to correspondingly always verify the current setting for the used instrument; that in general a stopper should be used with a biopsy needle.Additionally, the use of a stopper might also aid to detect an insertion potentially not yet deep enough for the intended target; despite not being the root cause for this issue here: brainlab has not validated the marker spheres nor the biopsy cannula used by this hospital in conjunction with the brainlab navigation system, and therefore brainlab is not in a position to determine the accuracy, compatibility or safety of these other marker spheres nor this other biopsy cannula.

Event Description

A cranial surgery for a biopsy of a cyst (from tumor resection) located ca.40mm deep in the brain (pre-central region) with a size of ca.50mm, has been performed with the aid of the virtual display of the brainlab navigation.A pre-operative mri was acquired before the surgery, to use with navigation.A trajectory for the biopsy was pre-operatively planned on that mri.During the procedure the surgeon: performed the initial patient registration on the pre-op mri to match the virtual display of the navigation to the current patient anatomy; verified the accuracy of the registration on the patient's skin to be acceptable for use; located the target with the navigated pointer using the "tool tip offset" function, with an offset of 20mm added, and marked the target location on the patient's skin; draped the patient, re-checked accuracy, created a burr hole, set the trajectory path and placed a navigated biopsy needle with the aid of brainlab navigation and the preplanned target point; took 3 biopsy samples with 3 needle insertions, and determined from the consistency of the samples that they were not from the intended target (cyst), without needing to send them to pathology first; removed the "tool tip offset" in the navigation, and took 2 further biopsy samples with 2 needle insertions with still the same trajectory path set at the same surgery.These 2 biopsies were successful and contained the expected fluid samples from the desired target (cyst).These samples were sent to pathology.According to the surgeon: a post-operative mri scan confirmed that the trajectory path of the biopsies was correct as intended, and that the unsuccessful biopsy samples were taken in the correct path, but 20mm before the intended target (corresponding to the "tool tip offset" used); there were no negative clinical effects to this patient due to this issue / biopsy resection at this surgery; there was no (direct or increased) risk to harm a critical brain structure (e.G.Blood vessels or important brain tissue) due to the biopsy at location different than desired; there was also no negative effect to the patient due to anesthesia prolong (at this surgery of ca.20min prolong); there are no other remedial actions necessary, done or planned for this patient due to this issue other than additional biopsy apply at same surgery to retrieve desired samples; the surgery was completed successfully as intended with desired samples retrieved at same surgery.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
• Type of Device: IMAGE 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: markus hofmann ; kapellenstrasse 12; feldkirchen, 85622 ; GM 85622 ; 89 9915680
• MDR Report Key: 5614854
• MDR Text Key: 43885705
• Report Number: 8043933-2016-00014
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22216A
• Device Catalogue Number: 71201A
• Device Lot Number: SW V. 3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other