MAUDE Adverse Event Report: BRAINLAB AG ENT NAVIGATION SOFTWARE (VERSION 2.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC

Model Number	22215-02C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Cerebrospinal Fluid Leakage (1772)
Date of Event	01/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A risk to the patient's health could not be excluded for these specific circumstances, since unintentionally too much was resected in the patient's left ethmoid sinus and a csf leak occurred with the brainlab device involved, despite according to the hospital: the csf leak was repaired successfully during the same surgery.The surgery was completed successfully as intended without navigation.There was no prolongation of anesthesia.The patient was transferred to the icu after the surgery; the duration of the hospitalization is not known as the surgeon was not willing to provide further information.The surgeon stated the patient is well, but was not willing to provide any further information about the patient outcome (including whether any further remedial actions were necessary, done or planned for this patient).According to the results of the brainlab investigation and the limited information provided by the hospital, it can be concluded that the root cause for the reported deviation between the display of navigation and the actual patient anatomy near the left ethmoid sinus is movement of the ent reference headband and array due to insufficient rigid fixation or inadvertent forces at or after draping during the surgery.Movement of the reference array cannot be compensated by the navigation system.Apparently the resulting deviation of the navigation display was not detected by the user with the necessary continued user verification of accuracy after draping and throughout the surgery.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 reiterate the relevant topics regarding the use of the device to this customer.
Event or Problem Description
What is the issue? a functional endoscopic sinus surgery (fess) was performed with the aid of the display by the brainlab navigation software (b)(4) a preoperative ct scan was acquired 24 days prior to the surgery, to use with navigation.During the procedure the surgeon: positioned the patient in supine position and attached the brainlab reference headband and reference array for navigation.Performed the initial patient registration on the preoperative ct acquiring registration points on the patient's skin to match the display of the navigation to the current patient anatomy.Verified the accuracy of the registration, accepted the registration to proceed, and draped the patient.Began the surgery using an endoscope, non-navigated instruments (debrider and forceps), and the navigated brainlab pointer, which was used for general navigation guidance throughout the procedure.While performing the resection in the left ethmoid sinus, noticed the position of the pointer displayed by navigation did not correlate to anatomical landmarks seen in the endoscopic image, and determined too much had been resected due to this deviation of navigation.A second surgeon came in to consult and detected a csf leak.The second surgeon repaired the csf leak and the surgery was continued and completed successfully as intended without navigation.According to the hospital: the csf leak was repaired successfully during the same surgery.The surgery was completed successfully as intended without navigation.There was no prolongation of anesthesia.The patient was transferred to the icu after the surgery; the duration of the hospitalization is not known as the surgeon was not willing to provide further information.The surgeon stated the patient is well, but was not willing to provide any further information about the patient outcome (including whether any further remedial actions were necessary, done or planned for this patient).

• Brand Name: ENT NAVIGATION SOFTWARE (VERSION 2.1)
• Common Device Name: IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): BRAINLAB AG; olof-palme-strasse 9; muenchen, 81829 ; GM 81829
• MDR Report Key: 9727567
• Report Number: 8043933-2020-00011
• Device Sequence Number: 1965225
• Product Code: HAW
• UDI-Device Identifier: 04056481000486
• UDI-Public: 04056481000486
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K092467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 22215-02C
• Device Catalogue Number: 71087A
• Device Lot Number: SW V. 2.1.1.
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other