DICOM PROXY

Description of Event or Problem

A SURGERY (ON (B)(6) 2021) ON THE KNEE FOR ANTERIOR CRUCIATE LIGAMENT DISSECTION WAS PERFORMED WITH THE AID OF A NON-BRAINLAB DISPLAY THAT SHOWED THE IMAGE/VIDEO OF A NON-BRAINLAB ENDOSCOPE, AND A BRAINLAB SOFTWARE WAS INVOLVED IN THE ROUTING PROCESS OF THE VIDEO SIGNAL TO THE USED DISPLAY. DURING THE PROCEDURE THE NON-BRAINLAB DISPLAY DID NO LONGER SHOW THE VIDEO OF THE NON-BRAINLAB ENDOSCOPE, AND THE SURGEON REMOVED THE INSTRUMENT (SHAVER) WITHOUT AID OF THE DISPLAY. ACCORDING TO THE SURGEON, THE LOSS OF VISUAL CONTROL COULD HAVE LED TO HARM OF CRITICAL STRUCTURES IN THE KNEE (E.G. LIGAMENT), AND THUS IN A WORST CASE SCENARIO ULTIMATELY TO SERIOUS HARM TO THE PATIENT. ACCORDING TO THE HOSPITAL/SURGEON: THE SHAVER WAS IMMEDIATELY STOPPED AND REMOVED CAREFULLY FROM THE PATIENT WHEN THE ENDOSCOPE IMAGE WAS NO LONGER AVAILABLE (NO UNINTENDED SURGICAL STEPS WERE REPORTED TO HAVE BEEN PERFORMED DUE TO THE ISSUE). THERE WAS NO HARM/NEGATIVE CLINICAL EFFECT TO THE PATIENT DUE TO THIS ISSUE. THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS WERE REPORTED THAT WOULD HAVE BEEN NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THIS ISSUE (MERELY SURGERY/ANESTHESIA TIME WAS EXTENDED BY 10 MINUTES).

Additional Manufacturer Narrative

A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE UNINTENDED SURGICAL STEPS/CUTS COULD HAVE BEEN APPLIED IN A DIFFERENT LOCATION (IN THIS CASE IN THE KNEE) THAN ANTICIPATED, WITH THE BRAINLAB DEVICE INVOLVED IN THE ROUTING PROCESS OF THE VIDEO SIGNAL TO THE DISPLAY THAT THE USER RELIED ON DURING THE SURGERY, DESPITE ACCORDING TO THE SURGEON: THE SHAVER WAS IMMEDIATELY STOPPED AND REMOVED CAREFULLY FROM THE PATIENT WHEN THE ENDOSCOPE IMAGE WAS NO LONGER AVAILABLE (NO UNINTENDED SURGICAL STEPS WERE REPORTED TO HAVE BEEN PERFORMED DUE TO THE ISSUE). THERE WAS NO HARM/NEGATIVE CLINICAL EFFECT TO THE PATIENT DUE TO THIS ISSUE. THE OUTCOME OF THE SURGERY WAS SUCCESSFUL AS INTENDED. NO FURTHER MEDICAL/SURGICAL REMEDIAL ACTIONS WERE REPORTED THAT WOULD HAVE BEEN NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THIS ISSUE (MERELY SURGERY/ANESTHESIA TIME WAS EXTENDED BY 10 MINUTES). ACCORDING TO THE RESULTS OF THE TECHNICAL INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE ROOT CAUSE FOR THE UNEXPECTEDLY TERMINATED DISPLAY OF THE ENDOSCOPE VIDEO ON THE NON-BRAINLAB SCREEN (WITH ROUTING OF THE ENDOSCOPE VIDEO TO THE SCREEN INITIATED USING BRAINLAB SOFTWARE), THAT LED TO LOSS OF VISUAL CONTROL OF INSTRUMENTS (SHAVER) USED IN THIS KNEE SURGERY, IS A SOFTWARE CRASH/RESTART OF THE BRAINLAB BACKBONE APPLICATION (A SOFTWARE COMPONENT INSTALLED TOGETHER WITH THE DICOM PROXY) DUE TO A SOFTWARE ERROR. DETAILS: THE CRASH WAS CAUSED BY A "RACE CONDITION" (TWO PARALLEL THREADS OF EXECUTION ACCESSING THE SAME DATA AT THE EXACT SAME TIME) THAT OCCURRED WHEN THE USER STARTED THE RECORDING OF THE SCREEN DISPLAYING THE ENDOSCOPE VIDEO. DURING RESTART OF THE BACKBONE APPLICATION THE BRAINLAB BACKGROUND/LOGO WAS DISPLAYED ON ALL AVAILABLE SCREENS EXCEPT MAIN SCREEN (INTENDED BEHAVIOR), THEREBY REPLACING THE ENDOSCOPE VIDEO. APPARENTLY, THE USER WAS AWARE HOW TO RESTORE THE ROUTING, SINCE THE ENDOSCOPE VIDEO WAS DISPLAYED ON THE (NON-BRAINLAB) MAIN SCREEN APPROX. 3 SECONDS AFTER THE BACKBONE APPLICATION CRASH/RESTART. FOR UNKNOWN REASONS THE USER THEN SHUTDOWN AND REBOOTED THE (WHOLE) SYSTEM, WHICH REPORTEDLY WAS WORKING AFTER ITS REBOOT, BEFORE SUCCESSFULLY COMPLETING SURGERY. NOTE: ALTERNATIVELY, THE USER COULD HAVE MANUALLY ACTIVATED THE DISPLAY OF THE ENDOSCOPE VIDEO ON THE AVAILABLE (NON-BRAINLAB) FAILOVER SCREEN (WITH DATA TRANSFERRED VIA THE FAILOVER CABLE DIRECTLY FROM THE ENDOSCOPE TO THE FAILOVER SCREEN). TO CLARIFY, NO INCORRECT INFORMATION WAS DISPLAYED, NOR ANY INFORMATION THAT MIGHT MISLEAD THE USER IN REGARD TO CLINICAL DECISION MAKING, BUT THE DISPLAYED INFORMATION BECAME UNAVAILABLE FOR A TIME INTERVAL OF A FEW SECONDS (AND MEASURES WERE IN PLACE). ALREADY DONE: BRAINLAB CORRECTED THIS SOFTWARE ERROR IN FUTURE VERSIONS OF THE PRODUCT. FURTHER, BRAINLAB INTENDS TO RE-ITERATE THE RELEVANT TOPICS REGARDING THE USE OF THE DEVICE TO THIS CUSTOMER AND OFFER A GENERAL PRODUCT TRAINING TO THIS CUSTOMER.