TGS Navigation 8000-010-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327413083), received between Mar 28, 2023 and Jul 29, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: INCORRECT MEASUREMENT. 1 EVENT HAD INSUFFICIENT INFORMATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646524 ↗
• MalfunctionApr 21, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCORRECT MEASUREMENT. - 4 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875886 ↗
• MalfunctionJan 21, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY HAD AN INCORRECT MEASUREMENT. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200736 ↗
• MalfunctionOct 23, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE HAS ACCURACY ISSUES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17983807 ↗
• MalfunctionJun 15, 2023Incorrect Measurement; Device Displays Incorrect Message; Incorrect Measurement; Device Displays Incorrect Message

  PER THE CUSTOMER THERE WAS A LAG IN THE VIDEO DURING A PROCEDURE WHICH COULD CAUSE AN INACCURACY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17134152 ↗
• MalfunctionMar 28, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE FIELD GENERATOR PERCENTAGE WAS AT 98% WITH A REGISTRATION QUALITY OF .4 INSTRUMENTS WERE CONSISTENTLY SHOWING AS OFF TO THE PATIENTS LEFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16633066 ↗