Carto ENT 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10846835017182), received between Apr 10, 2018 and Apr 3, 2024 — classified as 8 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Image Orientation Incorrect” (12 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  A PATIENT UNDERWENT A BALLOON SINUPLASTY PROCEDURE WITH A WITH A TRUDI¿ NAVIGATION SYSTEM AND THE PATIENT EXPERIENCED CAROTID ARTERY INJURY THAT REQUIRED INTUBATION AND BALLOON INFLATION IN THE SINUS TO STOP BLEEDING AND PROLONGED HOSPITALIZATION. IT WAS INITIALLY REPORTED THAT THE DILATION OF THE SPHENOID SINUS LED TO THE CAROTID ARTERY BLOWING. THEY LEFT THE BALLOON INFLATED IN THE SINUS TO STOP THE BLEEDING. EMERGENCY MEDICAL TECHNICIANS (EMT)S CAME AND HAD TO INTUBATE. THE PATIENT WAS DOING BETTER. THE PHYSICIAN¿S OPINION, ON WHAT CONTRIBUTED TO THE ADVERSE EVENT IS THAT IT WAS THE PATIENT¿S UNIQUE ANATOMY. PHYSICIAN DID NOT FEEL ACCLARENT TECHNOLOGY WAS DEFECTIVE OR RESPONSIBLE FOR THE INJURY. OTHER DETAILS PROVIDED INCLUDED THAT THE BALLOON WAS INFLATED TWICE BEFORE THE COMPLAINT OCCURRED. 0 DEGREE SCOPE WAS USED. PATIENT HAS NOT UNDERGONE A PREVIOUS SINUS PROCEDURE. THERE WERE NO PERFORMANCE ISSUE / DEVICE MALFUNCTION ASSOCIATED WITH THE ACCLARENT BALLOON ACCLARENT DEVICES DURING THE PROCEDURE. ON 11-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVE INDICATING THE PATIENT¿S INJURY TO THE CAROTID ARTERY DURING A SINUS PROCEDURE ON (B)(6) 2023, CAUSED HER CATASTROPHIC NEUROLOGICAL

  Patient problems: Perforation of Vessels; Unspecified Nervous System Problem

  MAUDE report 19036483 ↗
• InjuryApr 3, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  A PATIENT UNDERWENT A BALLOON SINUPLASTY PROCEDURE WITH A WITH A TRUDI¿ NAVIGATION SYSTEM AND THE PATIENT EXPERIENCED CAROTID ARTERY INJURY THAT REQUIRED INTUBATION AND BALLOON INFLATION IN THE SINUS TO STOP BLEEDING AND PROLONGED HOSPITALIZATION. IT WAS INITIALLY REPORTED THAT THE DILATION OF THE SPHENOID SINUS LED TO THE CAROTID ARTERY BLOWING. THEY LEFT THE BALLOON INFLATED IN THE SINUS TO STOP THE BLEEDING. EMERGENCY MEDICAL TECHNICIANS (EMT)S CAME AND HAD TO INTUBATE. THE PATIENT WAS DOING BETTER. THE PHYSICIAN¿S OPINION, ON WHAT CONTRIBUTED TO THE ADVERSE EVENT IS THAT IT WAS THE PATIENT¿S UNIQUE ANATOMY. PHYSICIAN DID NOT FEEL ACCLARENT TECHNOLOGY WAS DEFECTIVE OR RESPONSIBLE FOR THE INJURY. OTHER DETAILS PROVIDED INCLUDED THAT THE BALLOON WAS INFLATED TWICE BEFORE THE COMPLAINT OCCURRED. 0 DEGREE SCOPE WAS USED. PATIENT HAS NOT UNDERGONE A PREVIOUS SINUS PROCEDURE. THERE WERE NO PERFORMANCE ISSUE / DEVICE MALFUNCTION ASSOCIATED WITH THE ACCLARENT BALLOON / ACCLARENT DEVICES DURING THE PROCEDURE. ON 11-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVE INDICATING THE PATIENT¿S INJURY TO THE CAROTID ARTERY DURING A SINUS PROCEDURE ON (B)(6) 2023 CAUSED HER CATASTROPHIC NEUROLOGICAL

  Patient problems: Perforation of Vessels; Unspecified Nervous System Problem

  MAUDE report 19035162 ↗
• InjuryMar 25, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NASAL/SINUS ENDOSCOPY WITH A TRUDI¿ NAVIGATION SYSTEM AND THE PATIENT EXPERIENCED CAROTID ARTERY INJURY THAT RESULTED IN A STROKE. THE PATIENT SUSTAINED AN INJURY TO HER CAROTID ARTERY DURING A SINUS PROCEDURE ON (B)(6) 2022, WHICH WAS REPORTED TO BE THE CAUSE OF HER SUFFERING A CATASTROPHIC STROKE. M.D. WHO PERFORMED THE SINUS PROCEDURE (A BALLOON SINUPLASTY), USED A NAVIGATION BALLOON DILATION SYSTEM ALONG WITH OTHER COMPONENT PARTS MANUFACTURED BY ACCLARENT. ADDITIONAL PRODUCTS INCLUDE THE TRUDI¿ NAVIGATION SYSTEM. IT IS BELIEVED THE ACCLARENT NAVIGATION BALLOON DILATION SYSTEM AND IT¿S COMPONENT PARTS, INCLUDING ANY AL (ARTIFICIAL INTELLIGENCE SOFTWARE) MAY HAVE MALFUNCTIONED AND FAILED TO PERFORM AS INTENDED DURING THE PROCEDURE AND AS A RESULT THE PATIENT'S CAROTID ARTERY WAS INJURED. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION OR WHAT MEDICAL INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. ALTHOUGH NO SPECIFIC MALFUNCTION WAS REPORTED WITH THE TRUDI¿ NAVIGATION SYSTEM THE ADVERSE EVENT IS BEING CONSERVATIVELY REPORTED.

  Patient problems: Perforation of Vessels; Stroke/CVA

  MAUDE report 18970741 ↗
• InjuryMar 25, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A NASAL/SINUS ENDOSCOPY WITH A TRUDI¿ NAVIGATION SYSTEM AND THE PATIENT EXPERIENCED CAROTID ARTERY INJURY THAT RESULTED IN A STROKE. THE PATIENT SUSTAINED AN INJURY TO HER CAROTID ARTERY DURING A SINUS PROCEDURE ON (B)(6) 2022, WHICH WAS REPORTED TO BE THE CAUSE OF HER SUFFERING A CATASTROPHIC STROKE. M.D. WHO PERFORMED THE SINUS PROCEDURE (A BALLOON SINUPLASTY), USED A NAVIGATION BALLOON DILATION SYSTEM ALONG WITH OTHER COMPONENT PARTS MANUFACTURED BY ACCLARENT. ADDITIONAL PRODUCTS INCLUDE THE TRUDI¿ NAVIGATION SYSTEM. IT IS BELIEVED THE ACCLARENT NAVIGATION BALLOON DILATION SYSTEM AND IT¿S COMPONENT PARTS, INCLUDING ANY AL (ARTIFICIAL INTELLIGENCE SOFTWARE) MAY HAVE MALFUNCTIONED AND FAILED TO PERFORM AS INTENDED DURING THE PROCEDURE AND AS A RESULT THE PATIENT'S CAROTID ARTERY WAS INJURED. THERE IS NO INFORMATION ABOUT THE HOSPITALIZATION OR WHAT MEDICAL INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. ALTHOUGH NO SPECIFIC MALFUNCTION WAS REPORTED WITH THE TRUDI¿ NAVIGATION SYSTEM THE ADVERSE EVENT IS BEING CONSERVATIVELY REPORTED.

  Patient problems: Perforation of Vessels; Stroke/CVA

  MAUDE report 18970277 ↗
• MalfunctionSep 29, 2023Display or Visual Feedback Problem; Smoking; Material Integrity Problem; Display or Visual Feedback Problem; Smoking; Material Integrity Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT (EAR, NOSE & THROAT) PROCEDURE WITH A TRUDI¿ NAVIGATION SYSTEM AND THE DISPLAY MONITOR EMITTED SMOKE. IT WAS REPORTED BY THE CALLER THAT AFTER BOOTING UP THE TRUDI¿ NAVIGATION SYSTEM THE MONITOR DISPLAY HAD LINES ON THE BOTTOM OF THE DISPLAY AND THEN 5 MINUTES LATER THE MONITOR WAS SMOKING. THE SYSTEM WAS SHOT DOWN AND THE MONITOR WAS REMOVED AND REPLACED WITH ONE FROM ANOTHER SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE MONITOR WAS NEVER ON FIRE, BUT THAT THE BOTTOM CORNER LOOKED LIKE IT HAD BEEN SMASHED INTO SOMETHING. THE CORNER FRONT ¿GLASS¿ PART OF THE MONITOR WAS MISSING AND THE DISPLAY COMPONENTS UNDER IT WERE SMOKING, SO THEY TURNED IT OFF AND CONNECTED THE DISPLAY TO A DIFFERENT MONITOR THE HOSPITAL HAD ON HAND. ON (B)(6) 2023, IS WHEN BWI WAS MADE AWARE THAT WHEN A DIFFERENT ENTC RECONNECTED THE DAMAGED MONITOR THE FOLLOWING DAY, IT AGAIN SMOKED BUT DID NOT HAVE FLAMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17848411 ↗
• MalfunctionSep 28, 2023Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) REVISION SURGERY WITH A TRUDI¿ NAVIGATION SYSTEM AND A LOCATION INACCURACY OCCURRED. IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) REVISION SURGERY WITH A TRUDI¿ NAVIGATION SYSTEM AND A LOCATION INACCURACY OCCURRED. IT WAS REPORTED THAT THE TRUDI CURETTE WAS INACCURATE COMPARED TO THE SUCTION OF THE CURETTE ON THE SAME ANATOMY. IT WAS A 5-6MM DIFFERENCE. INACCURACY WAS DETERMINED WHEN THE INSTRUMENT APPEARED TO BE FAR INTO THE BRAIN WHEN SURGEON WAS TOUCHING SKULL BASE BONE. THE CUSTOMER HAD CONFIRMED ACCURACY USING THE REGISTRATION PROBE AFTER THE REGISTRATION PROCESS WAS COMPLETED AND ALSO CONFIRMED ACCURACY WITH KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION WHILE INSIDE THE NASAL CAVITY AND 4-5 PLACES ON THE FACE AND IN THE NOSE ON MANY KNOWN LANDMARKS BEFORE AND AFTER THE CURETTE ISSUE. ACCURACY WAS VALIDATED VIA A REGISTRATION PROBE (RP) THEN VIA INSTRUMENTS. THE PERSON PERFORMING THE REGISTRATION IS VERY FAMILIAR WITH THE TRUDI REGISTRATION PROCESS. THIS WAS NOT A REGISTRATION TECHNICAL ISSUE. AFTER A COUPLE OF HOURS OF THE PROCEDURE INCL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840216 ↗
• MalfunctionSep 28, 2023Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) REVISION SURGERY WITH A TRUDI¿ NAVIGATION SYSTEM AND A LOCATION INACCURACY OCCURRED. IT WAS REPORTED THAT THE TRUDI CURETTE WAS DISPLAYED INACCURATELY BY 5MM ON THE TRUDI¿ NAVIGATION SYSTEM DURING THE PROCEDURE IN THE OPERATING ROOM. THEY REPLACED THE TRUDI CURETTE TWO TIMES WITHOUT RESOLUTION. THE PROCEDURE CONTINUED WITHOUT RESOLUTION. THERE WAS NO PATIENT CONSEQUENCE, AS SUCH, NO MEDICAL INTERVENTION REQUIRED. NO NON-ACCLARENT DEVICES WERE USED, AND IT WAS CONSIDERED THE ACCLARENT DEVICES DID NOT FUNCTION AS EXPECTED. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, A PRODUCT INVESTIGATION IDENTIFIED A REPORTABLE PRODUCT MALFUNCTION ON 1-SEP-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17840091 ↗
• MalfunctionSep 28, 2023Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) WITH A TRUDI¿ NAVIGATION SYSTEM AND A LOCATION INACCURACY OCCURRED. IT WAS REPORTED THAT THE TRUDI CURETTE WAS INACCURATE COMPARED TO THE TRUDI NAV SUCTION DEVICE. THE TRUDI CURETTE WAS PLUGGED INTO THE WHITE DONGLE, AND TRUDI NAV SUCTION DEVICE WAS PLUGGED INTO THE PURPLE. THE CALLER REPORTED THAT THEY ISOLATED THE PROBLEM TO THE TRUDI CURETTE PLUGGED INTO THE WHITE DONGLE, VERSUS THE TRUDI NAV SUCTION DEVICE CONNECTED TO THE PURPLE DONGLE. THE PROCEDURE CONTINUED USING OTHER NAVIGATED INSTRUMENTS THAT WERE ACCURATE ON THE TRUDI NAVIGATION SYSTEM. ADDITIONAL INFORMATION RECEIVED INDICATED THAT WHEN THE ACCURACY ISSUE WAS OBSERVED, THE BAR BELOW THE DEVICE ICON ON THE TRUDI SYSTEM MONITOR WAS GREEN. THERE WERE NO ERROR MESSAGES ON THE TRUDI¿ NAVIGATION SYSTEM. THE DEVICE WAS PLUGGED IN AFTER THE REGISTRATION. THERE WAS NO MOVEMENT IN THE PATIENT TRACKER AND THIS WOULD NOT EXPLAIN THE INACCURACY SINCE THE SUCTION DEVICE REMAINED ACCURATE THROUGHOUT THE PROCEDURE. PER THE STANDARD ENVIRONMENT FOR A FESS - THE PATIENT HAD WAS TILTED AND MOVED WHEN SWITCHING BETWEEN SURGEONS AND WHEN SWITCHING FROM SE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839802 ↗
• MalfunctionSep 28, 2023Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) REVISION SURGERY WITH A TRUDI¿ NAVIGATION SYSTEM AND A LOCATION INACCURACY OCCURRED. AN ISSUE WAS REPORTED THE TRUDI CURETTE BEING "OFF" VERSUS THE SUCTION DEVICE WHEN COMPARED HEAD TO HEAD IN THE SAME ANATOMY. IN THIS CASE, THE CURETTE WAS ONLY OFF BY 2MM VERSUS THE SUCTION SO WAS TECHNICALLY WITHIN OUR LABELED SPECS - BUT THE SURGEON DID NOT FIND THE INACCURACY ACCEPTABLE. THERE WAS NO INJURY TO PATIENT. NO CONCERNS AT ALL RELATED TO THE PATIENT HEALTH OR SAFETY. TROUBLESHOOTING WAS COMPARING THE CURETTE (WHICH WAS APPEARING "OFF" EMBEDDED IN THE POSTERIOR TABLE BONE) DIRECTLY IN THAT SAME ANATOMY TO THE SUCTION DEVICE. THE SURGEON WHO REGISTERED HAD BEEN TRAINED AND HAD REGISTERED MULTIPLE TIMES. SINCE THE COMPLAINT IS ABOUT THE DIFFERENCE BETWEEN CURETTE AND SUCTION, REGISTRATION IS NOT THE ISSUE. THE ACCURACY WAS CONFIRMED USING THE REGISTRATION PROBE AFTER REGISTRATION PROCESS WAS COMPLETED AND WITH KNOWN LANDMARKS IN ENDOSCOPIC VISUALIZATION INSIDE THE NASAL CAVITY. INACCURACY WAS CONFIRMED MULTIPLE WAYS DURING REGISTRATION AND ON ALL AREAS OF THE FACE WITH THE REGISTRATION PROBE (RP) AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839740 ↗
• MalfunctionSep 28, 2023Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) WITH A TRUDI¿ NAVIGATION SYSTEM AND A LOCATION INACCURACY OCCURRED. IT WAS REPORTED THAT DURING A PRIMARY SURGERY, THE TRUDI CURETTE WAS DISPLAYED ON THE TRUDI SYSTEM INACCURATELY AND IN THE BRAIN. THE CALLER STATED THAT THE TRUDI CURETTE WAS DISPLAYED ON THE TRUDI SYSTEM ABOUT 4MM OFF IN COMPARISON TO THE SUCTION DEVICE THAT WAS PLACED IN THE SAME LOCATION. ADDITIONAL INFORMATION RECEIVED INDICATED A LOCATION INACCURACY WAS DETERMINED ONLY IN THIS ONE AREA OF ANATOMY IN THE MIDDLE OF THE WORKFLOW OF THE CASE. IT WAS DETERMINED FROM THE CURETTE READING SIGNIFICANTLY DIFFERENTLY FROM SUCTION IN SAME EXACT ANATOMY. ADDITIONALLY, THE CURETTE WAS DEPICTED IN BRAIN 4MM ACROSS THE SKULL BASE BONE -RATHER THAN IN NASAL CAVITY WHERE SURGEON WAS OPERATING. ACCURACY HAD BEEN PREVIOUSLY VALIDATED BY BOTH USING THE REGISTRATION PROBE AND THROUGH INSTRUMENTATION. THE REGISTRATION WAS PERFORMED BY A FELLOW AND WAS GOOD. A FIRST REGISTRATION WAS PERFORMED AND HE ACCIDENTALLY HIT THE ¿BACK¿ BUTTON TO ACCEPT BEFORE HE WAS FINISHED. THEREFORE, WE RE-REGISTERED BEFORE STARTING THE CASE AND NOTED EXCELLENT ACCURACY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839604 ↗
• MalfunctionSep 28, 2023Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EAR, NOSE & THROAT PROCEDURE (ENT) PROCEDURE WITH A TRUDI¿ NAVIGATION SYSTEM AND A LOCATION INACCURACY OCCURRED. IT WAS REPORTED THAT THE TRUDI CURETTE WAS READING INACCURATELY IN THE BRAIN WHEN COMPARED TO THE TRUDI SUCTION DEVICE IN THE SAME POSITION. THE PROCEDURE CONTINUED WITHOUT RESOLUTION. ADDITIONAL INFORMATION RECEIVED INDICATED A LOCATION INACCURACY WAS DETERMINED ONLY IN THIS ONE AREA OF ANATOMY IN THE MIDDLE OF THE WORKFLOW OF THE CASE. IT WAS DETERMINED FROM THE CURETTE READING SIGNIFICANTLY DIFFERENTLY FROM SUCTION IN SAME EXACT ANATOMY. ADDITIONALLY, THE CURETTE WAS DEPICTED IN BRAIN 4MM ACROSS THE SKULL BASE BONE -RATHER THAN IN NASAL CAVITY WHERE SURGEON WAS OPERATING. ACCURACY HAD BEEN PREVIOUSLY VALIDATED BY BOTH USING THE REGISTRATION PROBE AND THROUGH INSTRUMENTATION. THE REGISTRATION WAS PERFORMED BY A FELLOW AND WAS GOOD. ACCURACY WAS CONFIRMED ON FOUR (4) AREAS OF THE FACE AND THEN INTRANASALLY ON KNOWN, FIXED LANDMARKS SUCH AS BACK OF MAXILLARY, FACE OF SPHENOID. MANY CT SCANS AT 0.75MM SCAN THICKNESS AND NEARLY WHOLE-HEAD COMPUTED TOMOGRAPHY(CT). FIELD OF VIEW WAS REPORTED TO BE GREAT AT IN ANGLED SCOPE. THERE WE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17839407 ↗
• MalfunctionSep 19, 2023Display or Visual Feedback Problem; Smoking; Display or Visual Feedback Problem; Smoking

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ENT (EAR, NOSE & THROAT) PROCEDURE WITH A TRUDI¿ NAVIGATION SYSTEM AND THE DISPLAY MONITOR EMITTED SMOKE. IT WAS REPORTED BY THE CALLER THAT AFTER BOOTING UP THE TRUDI¿ NAVIGATION SYSTEM THE MONITOR DISPLAY HAD LINES ON THE BOTTOM OF THE DISPLAY AND THEN 5 MINUTES LATER THE MONITOR WAS SMOKING. THE SYSTEM WAS SHOT DOWN AND THE MONITOR WAS REMOVED AND REPLACED WITH ONE FROM ANOTHER SYSTEM. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE MONITOR WAS NEVER ON FIRE, BUT THAT THE BOTTOM CORNER LOOKED LIKE IT HAD BEEN SMASHED INTO SOMETHING. THE CORNER FRONT ¿GLASS¿ PART OF THE MONITOR WAS MISSING AND THE DISPLAY COMPONENTS UNDER IT WERE SMOKING, SO THEY TURNED IT OFF AND CONNECTED THE DISPLAY TO A DIFFERENT MONITOR THE HOSPITAL HAD ON HAND. WHEN A DIFFERENT ENTC RECONNECTED THE DAMAGED MONITOR THE FOLLOWING DAY, IT AGAIN SMOKED BUT DID NOT HAVE FLAMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778232 ↗
• InjuryJan 26, 2023Image Orientation Incorrect; Patient Device Interaction Problem; Image Orientation Incorrect; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT WITH RECURRENT FUNGAL SINUSITIS WHO UNDERWENT EAR, NOSE & THROAT REVISION PROCEDURE WITH TRUDI NAVIGATION SYSTEM AND AN ISSUE OF ¿LOCATION INACCURACY¿ OCCURRED AND THE EXPERIENCED A SOFT TISSUE INJURY REQUIRING SURGICAL INTERVENTION. IT WAS REPORTED THAT A PENETRATION/PUNCTURE OF THE SKULL BASE NEXT TO THE POSTERIOR ETHMOID AREA OCCURRED DURING A REVISION SINUS SURGERY. THE CALLER REPORTED THAT THE SUCTION DEVICE WAS DISPLAYED ON THE TRUDI SYSTEM 1 CM FROM THE SKULL BASE WHICH RESULTED IN THE PHYSICIAN PUTTING A HOLE IN THE SKULL BASE WITH THE SUCTION DEVICE. IT WAS REPORTED THAT WHEN THE PHYSICIAN PLACED THE SUCTION DEVICE AT THE POINT WHERE HE SAW BRAIN MATTER, THE TRUDI SYSTEM STILL DISPLAYED THE SUCTION DEVICE AS 1 CM FROM THE SITE. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION, THE PHYSICIAN PATCHED THE HOLE AND THE GENERAL PROCEDURE WAS COMPLETED AFTER, THE PATIENT WAS DISCHARGED THE NEXT MORNING AND THAT THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE TRUDI SYSTEM WAS OFF BY AT LEAST ONE (1) CENTIMETER AT A CRITICAL LOCATION NEAR POSTERIOR ETHMOID. T

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16249147 ↗
• InjuryJan 26, 2023Image Orientation Incorrect; Patient Device Interaction Problem; Image Orientation Incorrect; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT WITH RECURRENT FUNGAL SINUSITIS WHO UNDERWENT EAR, NOSE & THROAT REVISION PROCEDURE WITH TRUDI NAVIGATION SYSTEM AND AN ISSUE OF ¿LOCATION INACCURACY¿ OCCURRED AND THE EXPERIENCED A SOFT TISSUE INJURY REQUIRING SURGICAL INTERVENTION. IT WAS REPORTED THAT A PENETRATION/PUNCTURE OF THE SKULL BASE NEXT TO THE POSTERIOR ETHMOID AREA OCCURRED DURING A REVISION SINUS SURGERY. THE CALLER REPORTED THAT THE SUCTION DEVICE WAS DISPLAYED ON THE TRUDI SYSTEM 1 CM FROM THE SKULL BASE WHICH RESULTED IN THE PHYSICIAN PUTTING A HOLE IN THE SKULL BASE WITH THE SUCTION DEVICE. IT WAS REPORTED THAT WHEN THE PHYSICIAN PLACED THE SUCTION DEVICE AT THE POINT WHERE HE SAW BRAIN MATTER, THE TRUDI SYSTEM STILL DISPLAYED THE SUCTION DEVICE AS 1 CM FROM THE SITE. ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION, THE PHYSICIAN PATCHED THE HOLE AND THE GENERAL PROCEDURE WAS COMPLETED AFTER, THE PATIENT WAS DISCHARGED THE NEXT MORNING AND THAT THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE TRUDI SYSTEM WAS OFF BY AT LEAST ONE (1) CENTIMETER AT A CRITICAL LOCATION NEAR POSTERIOR ETHMOID. T

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16248991 ↗
• InjuryNov 22, 2022Image Orientation Incorrect; Patient Device Interaction Problem; Image Orientation Incorrect; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ENT (EAR, NOSE & THROAT) PROCEDURE WITH A TRUDI¿ NAVIGATION SYSTEM WHICH ENCOUNTERED LOCATION INACCURACY ISSUES AND THE PATIENT SUFFERED CEREBROSPINAL FLUID LEAK. IT WAS REPORTED THAT THERE WERE CONSTANT ACCURACY ISSUES ON THE TRUDI¿ NAVIGATION SYSTEM WITH ALL THE DEVICES INVOLVED IN THE PROCEDURE DEVICES ABOUT HALFWAY THROUGH THE PROCEDURE. IT WAS NOTED THAT THE SYSTEM WAS REREGISTERED A FEW TIMES AND THE ISSUE WOULD TEMPORARILY RESOLVE, BUT AS THE CASE PROCEEDED, THE ISSUE WOULD OCCUR AGAIN. IT WAS ALSO NOTED THAT THE EMITTER PAD HAD MOVED SLIGHTLY, AND THE PATIENT'S HEAD HAD MOVED A FEW TIMES THROUGHOUT THE PROCEDURE. IT WAS ALSO NOTED THAT THE PATIENT WAS IN REVERSE TRENDELENBURG AND ANGLED TO THE PHYSICIAN AND LOWERED ON THE BED BY A FEW INCHES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS ALSO REPORTED THAT THE PATIENT WAS DISCHARGED FOLLOWING THE ENT PROCEDURE ON (B)(6) 2022 AND THE PATIENT WENT TO THE ER ON (B)(6) 2022. NO PATIENT'S SYMPTOMS WERE REPORTED AND NO INFORMATION ON HOW THE CEREBROSPINAL FLUID LEAK WAS VERIFIED. NO INFORMATION WAS PROVIDED REGARDING MEDICAL INTERVENTION REQUIRED BUT THE PATIENT WAS REPORTED TO BE I

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 15844941 ↗
• InjuryNov 22, 2022Image Orientation Incorrect; Patient Device Interaction Problem; Image Orientation Incorrect; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT ENT (EAR, NOSE & THROAT) PROCEDURE WITH A TRUDI¿ NAVIGATION SYSTEM WHICH ENCOUNTERED LOCATION INACCURACY ISSUES AND THE PATIENT SUFFERED CEREBROSPINAL FLUID LEAK. IT WAS REPORTED THAT THERE WERE CONSTANT ACCURACY ISSUES ON THE TRUDI¿ NAVIGATION SYSTEM WITH ALL THE DEVICES INVOLVED IN THE PROCEDURE DEVICES ABOUT HALFWAY THROUGH THE PROCEDURE. IT WAS NOTED THAT THE SYSTEM WAS REREGISTERED A FEW TIMES AND THE ISSUE WOULD TEMPORARILY RESOLVE, BUT AS THE CASE PROCEEDED, THE ISSUE WOULD OCCUR AGAIN. IT WAS ALSO NOTED THAT THE EMITTER PAD HAD MOVED SLIGHTLY, AND THE PATIENT'S HEAD HAD MOVED A FEW TIMES THROUGHOUT THE PROCEDURE. IT WAS ALSO NOTED THAT THE PATIENT WAS IN REVERSE TRENDELENBURG AND ANGLED TO THE PHYSICIAN AND LOWERED ON THE BED BY A FEW INCHES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS ALSO REPORTED THAT THE PATIENT WAS DISCHARGED FOLLOWING THE ENT PROCEDURE ON (B)(6) 2022 AND THE PATIENT WENT TO THE ER ON (B)(6) 2022. NO PATIENT'S SYMPTOMS WERE REPORTED AND NO INFORMATION ON HOW THE CEREBROSPINAL FLUID LEAK WAS VERIFIED. NO INFORMATION WAS PROVIDED REGARDING MEDICAL INTERVENTION REQUIRED BUT THE PATIENT WAS REPORTED TO BE I

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 15844927 ↗
• MalfunctionSep 6, 2022Fire; Overheating of Device; Material Integrity Problem; Fire; Overheating of Device; Material Integrity Problem

  IT WAS REPORTED THAT THE TRUDI¿ NAVIGATION SYSTEM¿S MONITOR ENCOUNTERED SOME HEAT DAMAGE AND IS CONSIDERED AS A FIRE HAZARD. IT WAS REPORTED THAT THE TRUDI¿ NAVIGATION SYSTEM¿S 32 INCH MONITOR HAS HEAT DAMAGE IN ONE OF THE CORNERS, AND IT IS NOT FUNCTIONING. THE MONITOR WAS DESCRIBED TO HAVE ¿NOT POWER ON AT ALL¿. THE TRUDI NAVIGATION SYSTEM SOFTWARE VERSION IS REPORTED TO BE 2.3. ADDITIONAL INFORMATION RECEIVED INDICATED THE HEAT DAMAGE HAPPENED BECAUSE AN INTERNAL COMPONENT OF THE MONITOR BURNED THROUGH THE SCREEN. HENCE, THIS IS CONSIDERED AS A FIRE HAZARD RISK. WITH ALL THIS INFORMATION PROVIDED, THIS EVENT IS CONSIDERED AS A MALFUNCTION OF THE DEVICE AND CONSIDERED TO BE AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15366804 ↗
• MalfunctionMay 2, 2018Image Orientation Incorrect; Device Issue; Image Orientation Incorrect; Device Issue

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE WITH A CARTO ENT. THE ACCURACY WAS FINE ONCE THE WIRE ENTERED INTO THE NASAL CAVITY. HOWEVER, ONCE THE WIRE WENT DEEPER INTO THE NASAL CAVITY, IT LOST ACCURACY AND THE METAL INTERFERENCE READINGS WERE HIGH. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS RECEIVED WHICH CONFIRMED THAT THE BALLOON WAS NOT INFLATED DURING THE PROCEDURE AND THERE WAS NO ISSUE CAUSED. THEREFORE, NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE METAL INTERFERENCE ISSUE WAS ASSESSED AS NOT REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY WAS REMOTE. THE LOCATION ACCURACY ISSUE WAS ASSESSED AS A REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7481725 ↗
• MalfunctionApr 10, 2018Image Orientation Incorrect; Image Orientation Incorrect

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT A PROCEDURE WITH A CARTO ENT SYSTEM WHEREIN THE CARTO ENT NAVIGATION SYSTEM DID NOT ACCURATELY DISPLAY THE ANATOMY OF THE LEFT SIDED SINUSES. WHEN DILATION OF THE RIGHT-SIDED SINUSES WAS PERFORMED THE ANATOMY WAS DISPLAYED PROPERLY. WHEN THE LEFT-SIDED SINUSES WERE BEING DILATED THE SYSTEM STILL DISPLAYED THE BALLOON AS IF IN THE RIGHT-SIDED SINUSES. THE CUSTOMER RE-REGISTERED ANATOMY TWICE WITH THE REGISTRATION PROBE WITHOUT RESOLUTION. NO ERRORS WERE PRESENT. THE PHYSICIAN ABANDONED USE OF THE NAVIGATION SYSTEM AND PROCEEDED WITH THE CASE MANUALLY WITH THE LUMA WIRE. ON 04/06/2018, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ULTIRRA BALLON WITHOUT NAVIGATION. IT ALSO CONFIRMS THAT NO PATIENT CONSEQUENCES WERE REPORTED DURING THE CASE. THE PATIENT DID NOT REQUIRE MEDICAL OR SURGICAL INTERVENTION NEITHER EXTENDED HOSPITALIZATION, HOWEVER, THIS EVENT HAS BEEN DETERMINED TO BE A REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7413155 ↗