TruDi Probe TDP0705ZRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705031464220), received between Mar 10, 2023 and Mar 10, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Incorrect Interpretation of Signal” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2023Incorrect Interpretation of Signal; Incorrect Interpretation of Signal

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PRIMARY BALLOON SINUPLASTY (BSP) ON (B)(6) 2023, THE FOLLOWING PROCEDURES WERE PERFORMED: RIGHT MAXILLARY ANTROSTOMY, SPHENOIDOTOMY, AND FRONTAL TISSUE REMOVAL, IT WAS REPORTED THAT THE MORE POSTERIOR THE DISPOSABLE DEVICES WERE IN THE SPHENOID, THE LESS ACCURATE THE DEVICES WERE DISPLAYED ON THE TRUDI SYSTEM. THE ISSUE OCCURRED WITH TWO (2) DIFFERENT 0-DEGREE SUCTION DEVICES (TDNS000Z / LOT# UNKNOWN), AND A 70-DEGREE TRUDI PROBE (TDP0705Z / 210921B-PC). IT WAS REPORTED THAT THE DEVICES WERE ACCURATELY DISPLAYED ON THE TRUDI SYSTEM WHEN THEY WERE IN THE POSTERIOR NASOPHARYNX. THE PROCEDURE WAS CONTINUED WITHOUT RESOLUTION. THERE WAS NO PATIENT INJURY REPORTED. ON (B)(6) 2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THERE WAS NO ERROR MESSAGE DISPLAYED ON THE TRUDI SYSTEM MONITOR WHEN THE INACCURACY ISSUE WAS NOTED. THE ICON ON THE TRUDI SYSTEM WAS GREEN FOR ALL THREE (3) DEVICES WHEN THE ACCURACY ISSUE WAS OBSERVED. THE DEVICES WERE ¿ALL ACCURATE EVERYWHERE EXCEPT THE POSTERIOR SPHENOID. THEY WERE EVEN ACCURATE IN THE POSTERIOR NASOPHARYNX.¿ THE DEVICES WERE REPORTEDLY PLUGGED IN AFTER USING THE REGISTRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526124 ↗