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

Model Number 22216A

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

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

Event Date 12/13/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since biopsies were applied in a different location in the brain than intended with the brainlab device involved, despite according to the surgeon: - the surgery was to retrieve diagnostic sample a diagnostic sample, not to remove or treat the lesion.- there were no negative effects to the patient, neither due to biopsies nor prolong of surgery/anesthesia (of ca.1 hr.).- the surgery was re-scheduled to another day to retrieve a diagnostic sample.- there are no other remedial actions necessary, done or planned for this patient due to this issue.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 biopsies taken in a location different than intended with navigation involved, is a combination of the following factors: - the marker spheres used at this surgery were not new/unused as required.- the navigation ir camera was placed outside the recommended distance to the reference array.Further potential contributing factors at this specific surgery are: - the tip of one of the hospital's navigation pointers is visibly broken, the use of this pointer at this specific surgery cannot be excluded.- the patient's head might have moved within the (non-brainlab) head holder, and/or the reference array attached to the (non-brainlab) head holder might have moved during the surgery due to drilling or draping.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.

Event Description

A cranial surgery for a biopsy (for retrieval of a diagnostic sample) of a lesion with a size of ca 12 x 26 mm, located ca.30 mm deep in the brain, has been performed with the aid of the virtual display of the brainlab navigation version 3.1.A pre-operative ct scan was acquired the day before the surgery, to use with navigation.A trajectory was planned on the pre-op ct scan before the surgery with the brainlab iplan planning sw.During the procedure the surgeon: - positioned the patient in a supine orientation in a (non-brainlab) head holder.- performed the initial patient registration on the pre-op ct with surface matching to match the virtual display of the navigation to the current patient anatomy.- verified the accuracy of the registration and determined the result as very good.- draped the patient, created a burr hole, and took 2 biopsy samples with a navigated biopsy needle.These samples were non-pathological, i.E.Not from the tumor.- took a further biopsy sample with a manually calibrated biopsy needle, also this sample was non-pathological.The surgeon decided to finish the surgery and closed the patient, for re-schedule of the surgery.A post-op ct was taken and the fusion of the pre-op and post-op cts shows a deviation of the trajectory from the planned position of ca.13 mm.According to the surgeon: - the surgery was to retrieve a diagnostic sample, not to remove or treat the lesion.- there were no negative effects to the patient, neither due to biopsies nor prolong of surgery/anesthesia (of ca.1 hr.).- the surgery was re-scheduled to another day to retrieve a diagnostic sample.- there are no other remedial actions necessary, done or planned for this patient due to this issue.

• Brand Name: CRANIAL NAVIGATION SOFTWARE (VERSION 3.1)
• 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: markus hofmann ; olof-palme-strasse 9; münchen, 81829 ; GM 81829 ; 89 9915680
• MDR Report Key: 6263215
• MDR Text Key: 65240295
• Report Number: 8043933-2017-00002
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000479
• UDI-Public: 04056481000479
• 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: Physician
• Type of Report: Initial
• Report Date: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 22216A
• Device Catalogue Number: 71202A
• Device Lot Number: SW V. 3.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• 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