Scopis 8000-021-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07613327514179), received between Jun 5, 2023 and Apr 22, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (19 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 4, 2024Class IIOpen, Classified

   Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction.

   Z-1885-2024 · Root cause: Software Manufacturing/Software Deployment · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 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 NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954034 ↗
• MalfunctionJan 23, 2026Incorrect Measurement

  NO CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24164246 ↗
• MalfunctionJul 29, 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 APRIL 1 ¿ JUNE 30 2025. THIS REPORT SUMMARIZES 6 EVENTS FOR THE FAILURE: INCORRECT MEASUREMENT. - 5 EVENTS HAD NO HEALTH CONSEQUENCES OR IMPACT. - 1 EVENT HAD PROLONGED SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647405 ↗
• MalfunctionApr 21, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCORRECT MEASUREMENT. 2 EVENTS HAD PATIENT INVOLVEMENT: NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875917 ↗
• MalfunctionJan 21, 2025Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCORRECT MEASUREMENT. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21200737 ↗
• MalfunctionOct 21, 2024Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 12 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCORRECT MEASUREMENT. - 11 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT. - 1 EVENT LED TO A PROLONGED SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20497730 ↗
• MalfunctionJul 24, 2024Incorrect Measurement; Incorrect Measurement

  THIS REPORT SUMMARIZES 6 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY HAD AN INCORRECT MEASUREMENT. - 6 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19818520 ↗
• MalfunctionFeb 27, 2024Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER THE SCANS EITHER WILL NOT LOAD ON THE UNIT OR WILL LOAD THE IMAGES BACKWARDS SO THAT WHEN THE SURGEON IS OPERATING ON THE PATIENT LEFT, THE NAVIGATION/CT SCAN IS SHOWING THAT THEY ARE ON THE PATIENT RIGHT. 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 18790429 ↗
• MalfunctionFeb 27, 2024Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER THE SCANS EITHER WILL NOT LOAD ON THE UNIT OR WILL LOAD THE IMAGES BACKWARDS SO THAT WHEN THE SURGEON IS OPERATING ON THE PATIENT LEFT, THE NAVIGATION/CT SCAN IS SHOWING THAT THEY ARE ON THE PATIENT RIGHT. 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 18790425 ↗
• MalfunctionNov 15, 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 18144615 ↗
• MalfunctionNov 15, 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 18144497 ↗
• MalfunctionNov 1, 2023Incorrect Measurement; Incorrect Measurement

  PER THE CUSTOMER, THE DEVICE WAS INACCURATE DURING A PROCEDURE, SHOWING THE POINTS TO BE OFF FROM THE PHYSICAL REFERENCE POINT. 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 18046618 ↗
• 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 17967970 ↗
• 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 17967636 ↗
• 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 17967075 ↗
• 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 17965910 ↗
• 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 17965908 ↗
• MalfunctionJun 5, 2023Incorrect Measurement; Device Displays Incorrect Message; Incorrect Measurement; Device Displays Incorrect Message

  PER THE CUSTOMER THE VIDEO LAGGED DURING THE CASE WHICH CAN 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 17063787 ↗
• MalfunctionJun 5, 2023Incorrect Measurement; Device Displays Incorrect Message; Incorrect Measurement; Device Displays Incorrect Message

  PER THE CUSTOMER THE VIDEO LAGGED DURING THE CASE WHICH CAN 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 17059677 ↗