BRAINLAB AG CRANIAL NAVIGATION SOFTWARE (VERSION 3.1); IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC
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Model Number 22216-02C |
Device Problems
Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2022 |
Event Type
Injury
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Manufacturer Narrative
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A risk to the patient's health could not be excluded for these specific circumstances, since instrument paths and a biopsy was applied in a different location in the brain than anticipated, with the brainlab device involved, despite according to the surgeon: the deviation of the navigation was detected during the initial patient registration to the preoperative patient scan, however the surgeon accepted the registration to proceed, attempting to manually account for the inaccuracy.During the biopsy, the surgeon determined the navigation was still inaccurate (despite the attempt to manually correct) when the biopsy needle returned csf rather than tissue from the lesion.The outcome of the surgery was successful: the surgeon retracted the needle partially after initially retrieving only csf, and retrieved a tissue sample, which was confirmed to be diagnostic by pathology.There was no actual harm or negative clinical effect for the patient due to the biopsy, neither due to the prolongation of anesthesia/surgery by less than 30 minutes (despite there was an increased risk of harm since the biopsy needle was in the 4th ventricle).There were no further remedial actions necessary, done or planned for this patient due to the problem.Hospitalization was not prolonged either.According to the results of the brainlab investigation and the information provided by the hospital, it can be concluded that the root cause of the approximately 10-20mm inaccurate location (at the target) of the biopsy done with the aid of navigation was an insufficient distribution of points acquired by the user for patient anatomy registration to navigation, in combination with an inadequate patient scan used for registration, both not following brainlab requirements.Specifically, not many points were acquired on unique landmarks such as side or tip of the nose, and several points were acquired in areas where skin shift or distortion were present in the scan, from appliances (e.G.Headphones, head strap, etc.) used during the scan, not following brainlab requirements.This caused the cranial navigation software to not find an as accurate match in the region of interest as desired for this specific procedure in between the preoperative image dataset and the actual patient anatomy.As a potential contributing factor, a movement of the patient's head and/or patient reference array due to a non-rigid fixation and/or inadvertent forces applied after patient registration was performed cannot be completely ruled out.A movement of the patient's head relative to the reference array or vice versa cannot be compensated by the navigation system and can result in a deviation between the registered patient image and the actual patient.Note that an inaccurate registration (deviation of about 1cm in the anterior and cranial direction) was acknowledged and accepted by the user.However, apparently the full extent of the (overall) resulting deviation of the navigation display was not recognized by the user with the necessary navigation accuracy verification after registration, and throughout the procedure, and after draping, before the performing the biopsy.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.
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Event Description
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A cranial surgery for a diagnostic biopsy (only) of a lesion in the right posterior fossa at a depth of approximately 60mm, was performed with the aid of the display by the brainlab navigation software cranial 3.1.A pre-operative mri was acquired on the same day of the surgery for use with navigation; fiducial markers were placed on the patient's head and were included in the scan for use with navigation.During the procedure the surgeon: positioned the patient prone and secured the patient's head in a non-brainlab head clamp.Performed the initial patient registration to the preoperative mri by acquiring registration points at the fiducial markers on the patient to match the display of the navigation (of the preoperative mri) to the current patient anatomy.Verified the accuracy of the registration and deemed it not yet acceptable, and performed the registration with the fiducial markers twice again, but still determined the registration was not acceptable.Performed a fourth registration, this time without using the fiducial markers, but rather simply acquiring registration points on the patient's skin to match the display of the navigation (of the preoperative mri) to the current patient anatomy.Verified the accuracy of the fourth registration and noted a deviation of the navigation of at least 1cm in the anterior and cranial direction, judged it as less than optimal but deemed it sufficient for this procedure, and accepted this registration result to proceed.Draped the patient and performed the initial skin incision.Determined placement of the entry point (burr hole) with navigation, and created the burr hole in the patient's bone.Positioned the navigated frameless biopsy system over the burr hole to align with the lesion, and passed the navigated biopsy needle through the frameless biopsy system to the intended target lesion (as displayed on the preoperative mri in the navigation software).Collected a sample from the biopsy needle: only fluid (csf) was returned by the needle, so the surgeon determined (based on his experience and the anatomy) that the needle was in the fourth ventricle instead of at the planned target (lesion).Retracted the biopsy needle about 1cm and retrieved another sample which collected tissue; this sample was sent to pathology and was confirmed to be diagnostic (malignant glioma).Completed the surgery.According to the surgeon: the deviation of the navigation was detected during the initial patient registration to the preoperative patient scan, however the surgeon accepted the registration to proceed, attempting to manually account for the inaccuracy.During the biopsy, the surgeon determined the navigation was still inaccurate (despite the attempt to manually correct) when the biopsy needle returned csf rather than tissue from the lesion.The outcome of the surgery was successful: the surgeon retracted the needle partially after initially retrieving only csf, and retrieved a tissue sample, which was confirmed to be diagnostic by pathology.There was no actual harm or negative clinical effect for the patient due to the biopsy, neither due to the prolongation of anesthesia/surgery by less than 30 minutes (despite there was an increased risk of harm since the biopsy needle was in the 4th ventricle).There were no further remedial actions necessary, done or planned for this patient due to the problem.Hospitalization was not prolonged either.
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