Scopis ENT 8000-020-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 07613327413199), received between Jun 30, 2022 and Apr 22, 2026 — classified as 1 injury, 32 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (32 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Incorrect Measurement

  THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JANUARY 1 ¿ MARCH 31 2026. THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: INCORRECT MEASUREMENT. 1 EVENT HAD PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953600 ↗
• 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 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 24163974 ↗
• 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 22646522 ↗
• MalfunctionApr 21, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 4 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCORRECT MEASUREMENT. - 3 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 1 EVENT HAD INSUFFICIENT INFORMATION RECEIVED REGARDING HEALTH IMPACT.

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

  MAUDE report 21875883 ↗
• MalfunctionJan 21, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 7 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCORRECT MEASUREMENT. 6 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. 1 EVENT HAD A PROLONGED SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200753 ↗
• MalfunctionJul 24, 2024Incorrect Measurement; Incorrect Measurement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818528 ↗
• InjuryMay 20, 2024Incorrect Measurement; Incorrect Measurement

  PER THE ACCOUNT, DURING A CASE, THE PATIENT HAD A CSF LEAK AND THE DEVICE WAS INACCURATE. THE SURGEON WAS UNCLEAR IF THE DEVICE WAS THE CAUSE OF THE CSF LEAK. THE PATIENT WAS SENT TO A HOSPITAL FOR FURTHER EVALUATION. PER THE ACCOUNT AN ADDITIONAL SURGERY WAS REQUIRED TO REPAIR THE CSF LEAK. THE ADDITIONAL PROCEDURE TO REPAIR THE CSF LEAK WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 19353965 ↗
• MalfunctionMar 20, 2024Incorrect Measurement; Incorrect Measurement

  PER THE ACCOUNT, THE ACCURACY OF THE DEVICE DETERIORATES WHILE IN USE. AFTER INITIAL REGISTRATION, ACCURACY OF THE INSTRUMENTATION IS WITHIN SPECIFICATION. HOWEVER; AFTER ABOUT A HALF HOUR OF USE, THE IMAGE DATA DEVIATES CONSIDERABLY FROM THE ACTUAL PATIENT ANATOMY IN THE AXIAL VIEW "AXIS". AFTER THE OPERATION, IT WAS FOUND THAT THREE OF THE FIVE ANATOMICAL LANDMARKS HAD DEVIATIONS THAT WERE WELL ABOVE 1.5 MM. 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 18943527 ↗
• MalfunctionDec 27, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE WAS INACCURATE DURING A CASE. 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 18397363 ↗
• MalfunctionDec 15, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE PRECISION OF NAVIGATION DIVERTED BY 5-6 MM, DURING SURGERY. 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 18341509 ↗
• MalfunctionNov 20, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER THERE WAS A DEVIATION IN ACCURACY OF 3-4 MM INTRA-OPERATIVELY. 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 18171255 ↗
• MalfunctionNov 6, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, NAVIGATION LOST PRECISION DURING MEDICAL PROCEDURE. 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 18073297 ↗
• MalfunctionNov 2, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, DURING PROCEDURE, WHILE NAVIGATING, THE PRECISION WAS IMMEDIATELY AND ABRUPTLY LOST, THE TARGET POINT WAS SHIFTED BY 1CM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18059320 ↗
• MalfunctionOct 19, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE WOULD BE ACCURATE AT SOME POINTS DURING THE PROCEDURE, THEN BOTH WOULD SUDDENLY BE INACCURATE AT TIMES. 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 17965771 ↗
• MalfunctionOct 19, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE WAS INACCURATE BY 2MM DURING A PROCEDURE. THE CUSTOMER WAS UNABLE TO REGISTER THE DEVICE. 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 17965767 ↗
• MalfunctionOct 19, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE WAS INACCURATE BY 2MM DURING A PROCEDURE. THE CUSTOMER WAS UNABLE TO REGISTER THE DEVICE. 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 17965763 ↗
• MalfunctionOct 18, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER THE SYSTEM CONTINUES TO BE INACCURATE DESPITE ALL TROUBLESHOOTING EFFORTS. 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 17956817 ↗
• MalfunctionAug 31, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE WAS INACCURATE DURING A PROCEDURE. 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 17660104 ↗
• MalfunctionAug 30, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE WAS INACCURATE DURING A PROCEDURE. 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 17658222 ↗
• MalfunctionAug 29, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE WAS INACCURATE DURING A PROCEDURE. 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 17646940 ↗
• MalfunctionAug 15, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE WAS INACCURATE BY 1-2 CM DURING A CASE. 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 17548567 ↗
• MalfunctionJun 14, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE WAS INACCURATE. 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 17124340 ↗
• MalfunctionMay 19, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER THERE WERE MAJOR ACCURACY ISSUES WITH THEIR SCOPIS SYSTEM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY. NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16961302 ↗
• MalfunctionMay 3, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER DURING A PROCEDURE THE DEVICE WAS INACCURATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860531 ↗
• MalfunctionApr 28, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THERE WAS AN INCREASING INACCURACY DURING THE CASE. 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 16830722 ↗