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); Misassembly by Users (3133); Device Handling Problem (3265)

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

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

A risk to the patient's health could not be excluded for these specific circumstances, since a biopsy was 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 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 completed successfully as intended with viable biopsy sample retrieved as planned.- there are no other remedial actions necessary, done or planned for this patient due to this issue (except performing the additional biopsy at the same surgery).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 biopsy taken in a location different than intended with navigation involved, is that the sterile reference array for navigation was incorrectly mounted and thus not at the correct position.This led after exchange of the reference array to a navigation display of instrument positions different than originally registered to the ct scan.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.2x2cm, located left temporal in the brain, has been performed with the aid of the virtual display of the brainlab navigation version 3.1.A ct scan was acquired during the surgery, to use with navigation.Trajectories were planned on mri scans before the surgery.During the procedure the surgeon: - positioned the patient in a supine orientation.- performed the ct scan and the initial automatic patient registration to match the virtual display of the navigation on this image set to the current patient anatomy.- verified the accuracy of the registration and determined the result as very good.- draped the patient, exchanged the unsterile navigation reference array to a sterile reference array.- created a burr hole, and took a biopsy sample with a navigated biopsy needle.This sample was non-pathological, i.E.Not from the lesion.- performed another intra-operative ct scan with another automatic patient registration, and determined from this scan that the lesion had been missed (deviation from intended target was not measured).- took a further biopsy sample (using the existing burr hole) with a navigated biopsy needle using the new intra-operative ct scan.This sample was a pathological sample from the intended target as desired.- completed the surgery successfully as intended.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 completed successfully as intended with viable biopsy sample retrieved as planned.- there are no other remedial actions necessary, done or planned for this patient due to this issue (except performing the additional biopsy at the same surgery).

• 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: 6338555
• MDR Text Key: 67655684
• Report Number: 8043933-2017-00005
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 04056481000479
• UDI-Public: 04056481000479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092467
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• 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: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• 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