TruDi Probe TDP0705Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705031464209), received between Jun 20, 2022 and Feb 12, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING A TRUDI¿ NAVIGATION CASE IN THE OPERATING ROOM (OR), A CEREBROSPINAL FLUID OR CSF LEAK WAS NOTICED IN THE PATIENT. THE CALLER REPORTED THAT THERE WERE NO ISSUES OR ERRORS OBSERVED ON THE TRUDI¿ NAVIGATION SYSTEM. THE CALLER REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN HAD NOTICED A SMALL CEREBROSPINAL FLUID LEAK IN THE PATIENT. THE CALLER REPORTED THAT THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A MUCOSAL PATCH OR GRAFT. THE CALLER REPORTED THAT THE PATIENT WAS THEN SENT TO THE HOSPITAL FOR FURTHER MONITORING. THE CALLER WAS UNABLE TO CONFIRM IF THE PATIENT IS IN STABLE CONDITION AT THIS TIME. IT WAS ALSO REPORTED THAT THE FOLLOWING ACCLARENT PRODUCTS WERE USED DURING THIS CASE: RELIEVA SPINPLUS® NAV BALLOON - RSP0616MFSN. TRUDI¿ PROBE (70 DEGREE) - TDP0705. TRUDI¿ NAV SUCTION DEVICE (0 DEGREE) - TDNS000Z. TRUDI¿ NAV SUCTION DEVICE (70 DEGREE) - TDNS070Z. TRUDI¿ NAV SUCTION DEVICE (90 DEGREE) - TDNS090Z.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 21367398 ↗
• MalfunctionMay 24, 2024Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE, THE TRUDI PROBE, 70, 5IN (TDP0705, 230821A-PC) WAS OFF 3MM, INFERIOR. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. SURGERY WAS COMPLETED USING OTHER NAVIGATED INSTRUMENTS. THE PATIENT DID NOT EXPERIENCE ADVERSE EVENT. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-MAY-2024 INDICATED THAT WHEN THE ISSUE WITH THE SUCTION DEVICE OCCURRED, THE BAR COLOR WAS GREEN. THERE WAS NO ERROR MESSAGE. THE DEVICE WAS PLUGGED IN AFTER REGISTRATION. INACCURACY WAS DETERMINED BY VISUAL CONFIRMATION. PROBE PLACED VISUALLY ON SKULL BASE, SHOWED 3-4MM INFERIOR. THE CROSSHAIRS STAYED GREEN THE WHOLE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392813 ↗
• MalfunctionJan 31, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE ON (B)(6) 2023, THE TRUDI SYSTEM WAS NOT TRACKING THE TRUDI PROBE 70, 5IN (TDP0705 / LOT# UNKNOWN), THE 0° TRUDI NAV SUCTION DEVICE (TDNS000Z / LOT# UNKNOWN), AND THE 70° TRUDI NAV SUCTION DEVICE (TDNS070Z / LOT# UNKNOWN) WELL WHILE THE DEVICES WERE IN BOTH MAXILLARY SINUSES. THE REPORTED TRACKING ISSUE WAS DISCOVERED WHILE CHECKING ACCURACY ALONG THE POSTERIOR AND LATERAL WALL OF THE MAXILLARY SINUSES THAT THE TRUDI PROBE AND THE TWO SUCTION DEVICES WERE BOTH DISPLAYED INACCURATELY ON THE TRUDI SYSTEM BY ABOUT 5MM OFF. IT WAS ALSO REPORTED THAT THE TRUDI PROBE AND THE TWO SUCTION DEVICES WERE ALSO INACCURATELY DISPLAYED IN THE SPHENOID, ETHMOID, AND FRONTAL SINUSES. TROUBLESHOOTING WAS NOT PERFORMED. THE INDICATOR LIGHTS ON THE TRUDI SYSTEM FOR THE INSTRUMENTS WERE ALWAYS DISPLAYED AS GREEN. THE PROCEDURE WAS REPORTED AS COMPLETED. THERE WAS NO REPORT OF ANY PATIENT INJURY. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT ACCURACY WAS CONFIRMED USING THE REGISTRATION PROBE AFTER THE REGISTRATION PROCESS WAS COMPLETED. AFTER REGISTRATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16274806 ↗
• MalfunctionJun 20, 2022Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) AND SEPTOPLASTY PROCEDURE, THE LOCATION ACCURACY OF THE TRUDI PROBE 70, 5IN (TDP0705 / 210226B-PC) WAS OFF. THE LOCATION OF THE PROBE THAT WAS DISPLAYED ON THE TRUDI SYSTEM APPEARED TO BE 4 OR MORE MM OFF. THE FURTHER POSTERIOR AND SUPERIOR THAT THEY MOVED THE PROBE, THE LESS ACCURATE THE LOCATION OF THE PROBE SEEMED TO BE. THE PROBE WAS REGISTERED TWO TIMES WITHOUT RESOLUTION. THE PROCEDURE WAS CONTINUED WITHOUT THE USE OF THE PROBE. ON 01-JUN-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT WHEN THE ACCURACY ISSUE WAS NOTED, THE TRUDI PROBE WAS BEING HELD IN THE TRUDI ZONE. THE ICON ON THE TRUDI SYSTEM WAS GREEN. THERE WAS NO ERROR MESSAGE ON THE TRUDI NAV MONITOR FOR THE DEVICE. THE DEVICE WAS PLUGGED IN AFTER REGISTRATION (I.E., USING THE REGISTRATION PROBE). THE PATIENT TRACKER WAS NOT MOVED AND THE PATIENT TRACKER CABLE WAS NOT UNDER TENSION IN RELATION TO THE EVENT. TROUBLESHOOTING WAS PERFORMED IN THAT THE DEVICE WAS PLUGGED INTO A DIFFERENT PORT AS WELL AND IT WAS REGISTERED TWICE. THE INACCURACY WAS DETERMINED ¿FIRST BY THE SUCTIONS WHICH WERE PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14749157 ↗