With the currently available information, brainlab can neither exclude nor confirm that the brainlab device or its use caused or contributed to the death of the patient.Currently there is no indication of a systematic error or malfunction of the brainlab device, nor of insufficient measures to minimize this anticipated risk as low as reasonably practicable.A comprehensive investigation by brainlab regarding this specific event is currently ongoing and final conclusions are pending.Brainlab plans to issue a follow-up report upon completion of investigation.
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A right frontal burr hole and endoscopic (e.G.Direct visualization) resection of colloid cyst of 3rd ventricle with a stereotactic approach was performed with the aid of brainlab navigation system cranial 3.0.During the procedure the surgeon: performed an intraoperative ct scan using a non-brainlab ct scanner and accepted the automatic registration of the current patient anatomy to the navigation (to the intra-operative ct scan imported into and used by the navigation).Created a burr hole, and passed a sheath through the burr hole.Used the navigated brainlab pointer during the surgery with the sheath.Used a non-navigated non-brainlab endoscope through this sheath.At some point during the surgery, the surgeon detected a deviation of the display of navigation compared to the patient's anatomy.On (b)(6) 2020 brainlab was informed the patient died following complications, when brainlab received a request from the coroner for a report.
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B2, h1: brainlab is not aware of any allegation by the user that the observed deviation of the navigation display due to brain shift, when using the aid of the brainlab device (navigation), would have led to any treatment issues at this surgery or unintentional or deviating surgical actions performed under endoscopic sight, neither has this question been answered by the customer.Therefore, with the available information, brainlab can neither confirm nor exclude if the use of the additional aid of the brainlab navigation might have contributed to any potentially resulting effect to the patient, or to the death, in any way.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.H6: brainlab is not aware of any allegation by the user that the observed deviation of the navigation display, when using the aid of the brainlab device (navigation), would have led to any treatment issues at this surgery or unintentional or deviating surgical actions performed under endoscopic sight, neither has this question been answered by the customer.Despite brainlab's follow-up, the customer did not provide the necessary information for brainlab to perform a comprehensive investigation.The customer did not provide any further information about this surgery, therefore the investigation is limited to determining the cause of the reported deviation of the navigation display.According to the results of the brainlab investigation and the partial information available, it can be concluded that the main cause for the observed deviation of the navigation display is a shift of the patient's brain occurring during the procedure, and after the acquisition of the preoperative image data used with navigation, due to the opening of the ventricle, burr hole, and/or loss of cerebrospinal fluid.A shift of the patient's brain is typical for such a procedure in which the ventricle is opened (endoscopic resection of a colloid cyst).This shift of the patient's brain cannot be recognized or compensated by the navigation, which uses the preoperative image data for display of instrument positions relative to the patient's anatomy.Per information communicated by the surgeon to the brainlab representative during the surgery, the surgeon was confident that the deviation of the display of navigation compared to the patient's brain was due to displacement of the brain.With the information available, there is no indication of any other factors contributing to the detected deviation of the display of navigation.H7: brainlab intends to reiterate the relevant topics regarding the use of the device to this customer.
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A right frontal burr hole and endoscopic (e.G.Direct visualization) resection of colloid cyst of 3rd ventricle with a stereotactic approach was performed with the aid of brainlab navigation system cranial 3.0.During the procedure the surgeon: performed an intraoperative ct scan using a non-brainlab ct scanner and accepted the automatic registration of the current patient anatomy to the navigation (to the intra-operative ct scan imported into and used by the navigation).Created a burr hole, and passed a sheath through the burr hole.Used the navigated brainlab pointer during the surgery with the sheath.Used a non-brainlab endoscope through this sheath - it could not be confirmed if the endoscope was also navigated.At some point during the surgery, a deviation of the display of navigation compared to the patient's anatomy was detected.Brainlab was informed the patient died following complications, when brainlab received a request from the coroner for a report.
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