MAUDE Adverse Event Report: BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.0); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number 22216-01

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since an instrument path was applied in a different location in the brain than intended with the brainlab device involved, despite according to the hospital: a diagnostic sample was retrieved in a revision surgery performed on jun 23, 2020 (the same burr hole was used).There was no (direct or increased) risk to harm a critical structure due to the deviation in the initial surgery.There was no harm/negative clinical effect to this patient due to the deviation in the initial surgery (and also not due to repeat of anesthesia/surgery for 1 hour for the revision surgery).According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the main root cause for the deviation between the applied instrument path from the planned trajectory (approx.3 mm deviation in target point) is a combination of the following main factors: a bent pin detected on the varioguide array used during this procedure, which could lead to a deviation of displayed instrument position information.Less than ideal point acquisition by the user for patient registration with insufficient points acquired on the patient's left side/region of interest in combination with a poor quality mri scan that was used to register the patient for navigation, specifically significant skin shift in the scan (likely due to restraints) that could have negatively affected the accuracy of the registration result that was accepted for use with navigation.Apparently the resulting deviation of the navigation display was not detected by the user before performing invasive surgical steps, with the necessary continued user verification of accuracy after draping and throughout the surgery not sufficiently performed.There is no indication of a systematic error or malfunction of the brainlab device (navigation).Corresponding brainlab measures to minimize this anticipated risk as low as reasonably practicable are already in place.Brainlab intends to re-iterate the relevant topics regarding the use of the device to this customer.The affected varioguide array was removed from clinical use.

Event Description

A cranial surgery (on (b)(6) 2020) for biopsy (to retrieve a diagnostic sample), with approximated tumor volume of 7.5 cm³, located approx.6 cm in depth, was performed with the aid of the brainlab navigation software cranial 3.0.A pre-operative mri scan was acquired 13 days before the surgery (on (b)(6) 2020), to use with navigation.During the procedure the surgeon: positioned the patient in supine orientation in a non-brainlab head holder and attached the unsterile 4-sphere standard reference array.Planned a trajectory.Performed the initial patient registration on the pre-operative mri (surface matching without pre-registration points) using the z-touch, to match the display of the navigation to the current patient anatomy.Adjusted the reference array, performed a 2nd patient registration, and accepted the result after verification of registration accuracy.Aligned the varioguide to the planned trajectory and made the burr hole.- modified the entry point of the planned trajectory to match the exact location of the burr hole.Realigned the varioguide to the adjusted trajectory.Took 3 samples using the brainlab-distributed biopsy needle and ended surgery.According to the hospital/neurosurgeon: no diagnostic sample was retrieved in this surgery (note, this biopsy surgery was solely intended to retrieve a diagnostic sample, but not to treat the disease).A diagnostic sample was retrieved in a revision surgery performed on (b)(6) 2020 without aid of brainlab nav.Sw (the same burr hole was used).Hospitalization was prolonged to perform the revision surgery.There was no (direct or increased) risk to harm a critical structure due to the deviation in the initial surgery.There was no harm/negative clinical effect to this patient due to the deviation in the initial surgery (and also not due to repeat of anesthesia/surgery for 1 hour for the revision surgery).

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.0)
• Type of Device: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer (Section G): BRAINLAB AG; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• Manufacturer Contact: andrea miller ; olof-palme-strasse 9; münchen, 81829 ; GM 81829
• MDR Report Key: 10301320
• MDR Text Key: 204402264
• Report Number: 8043933-2020-00037
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481138790
• UDI-Public: 04056481138790
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22216-01
• Device Catalogue Number: 22216-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other