n/a 8000-040-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327413229), received between Jul 10, 2023 and Jan 23, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Incorrect Measurement

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN OCTOBER 1 ¿ DECEMBER 31 2025. THIS REPORT SUMMARIZES 5 EVENTS FOR THE FAILURE: INCORRECT MEASUREMENT. 4 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163396 ↗
• MalfunctionOct 28, 2025Incorrect Measurement; Incorrect Measurement

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1 ¿ SEPTEMBER 30 2025. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: INCORRECT MEASUREMENT. - 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399851 ↗
• MalfunctionJul 29, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: INCORRECT MEASUREMENT. 1 EVENT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22646530 ↗
• MalfunctionApr 21, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCORRECT MEASUREMENT. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875901 ↗
• MalfunctionJan 21, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCORRECT MEASUREMENT. - 1 EVENT HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21201192 ↗
• MalfunctionJul 24, 2024Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 8 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCORRECT MEASUREMENT. - 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 7 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19823145 ↗
• MalfunctionJul 24, 2024Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822988 ↗
• MalfunctionApr 22, 2024Incorrect Measurement; Incorrect Measurement

  WHILE BEING USED IN A CASE, THE DEVICE WAS INACCURATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153082 ↗
• MalfunctionMar 22, 2024Incorrect Measurement; Incorrect Measurement

  PER THE ACCOUNT, THE INTERFERENCE PERCENTAGE WOULD NOT GO OVER 85% DURING THE START OF A FUNCTIONAL ENDOSCOPIC SINUS PROCEDURE. LOWER INTERFACE PERCENTAGES DURING THE PROCEDURE COULD POTENTIALLY LEAD TO INACCURACIES. 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 18959601 ↗
• MalfunctionFeb 1, 2024Incorrect Measurement; Incorrect Measurement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18623719 ↗
• MalfunctionDec 27, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, DURING A CASE THE TRACKING QUALITY WAS NOT ACCURATE. 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 18398025 ↗
• MalfunctionDec 27, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, DURING A CASE THE TRACKING QUALITY WAS NOT ACCURATE. 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 18397851 ↗
• MalfunctionOct 9, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE PATIENT TRACKERS WOULD NOT GO ABOVE 85% INTERFERENCE CAUSING CONCERN WITH ACCURACY. 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 17895023 ↗
• MalfunctionOct 9, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE PATIENT TRACKERS WOULD NOT GO ABOVE 85% INTERFERENCE CAUSING CONCERN WITH ACCURACY. 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 17895021 ↗
• MalfunctionJul 10, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, WHILE NAVIGATING WITH A SCOPIS PRODUCT, THE DEVICE WAS CLEARLY INACCURATE IN THE LEFT MAXILLARY SINUS. THE SURGEON POINTED THIS OUT AND RE-REGISTERED THE PATIENT TO .45. THE PROBLEM CONTINUED AND A BACKUP DEVICE WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17290002 ↗