'"When you have your hands on something delicate, such as the brain, every
minute and second matters. Every small movement matters," says Moty Avisar,
CEO and co-founder of Surgical Theater. "If you have to pull your head away
from the microscope to look at a display and then go backwards, it disturbs
to continuity of the surgery."'

These systems capture real-time radiological imaging and overlay them with
augmented reality content—patient tissue/anatomy, position/orientation of
surgical instruments placed within, implanted electrodes, patient vitals
(pulse, oxygen saturation, blood pressure, etc.)—for rendering on a
heads-up display or goggle mounted display to minimize a surgeon's head
movements. The raw imaging + overlay is recorded.

The FDA's TPLC platform reports over 280 manufacturers of approved medical
devices that possess and perform "system, image processing, radiological"
capabilities, a label assigned to devices with product code LLZ. See
(retrieved on 18JUN2021) for device and patient issues reported between
01JAN2016 and 31MAY2021.

The number of deployed AR platforms, their frequency of use, surgery
procedure specialties, etc. are unknown. I count 619 device malfunctions, 35
injuries, and 4 deaths per medical device reports (MDRs) between 01JAN2016
and 31MAY2021 for the LLZ product code classification.

The top-10 Device Problems, in CSV format, are:

Device Problems,MDRs with this Device Problem,Events in those MDRs
Computer Software Problem,180,180
Loss of Data,137,137
Data Problem,108,108
Use of Device Problem,73,73
Patient Data Problem,52,52
Device Operates Differently Than Expected,47,47
Device Issue,37,37
Adverse Event Without Identified Device or Use Problem,27,27
Device Operational Issue,18,18
Application Program Problem: Parameter Calculation Error,17,17

The top-10 Patient Problems, in CSV format, are:

Patient Problems,MDRs with this Patient Problem,Events in those MDRs
No Known Impact Or Consequence To Patient,456,456
No Consequences Or Impact To Patient,69,69
No Clinical Signs,Symptoms or Conditions,55,55
No Patient Involvement,36,36
No Information,20,20
No Code Available,7,7
Failure of Implant,4,4
Insufficient Information,4,4
Missing Value Reason,4,4

By admin