OPTIS™ Integrated SystemRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00183739000937), received between Nov 6, 2018 and Oct 18, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN USING THE OPTIS INTEGRATED SYSTEM , AN UNSPECIFIED STENT WAS TO BE IMPLANTED. HOWEVER, THE RENDERING STENT SEEMS TO BE OFF 10MM. THE OUTCOME OF THE PROCEDURE IS UNKNOWN AT THIS TIME. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. FIELD SERVICE WILL BE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959089 ↗
• InjuryNov 16, 2021Communication or Transmission Problem; Communication or Transmission Problem

  DURING THE PROCEDURE, A ONE HOUR DELAY OCCURRED WHEN TWO CATHETERS COULD NOT BE CALIBRATED WITH THE SYSTEM. THE ERROR MESSAGE "PLEASE ADJUST THE CALIBRATION MANUALLY (CAL-002)." APPEARED. THE PROCEDURE WAS COMPLETED WITHOUT OCT AND THE PATIENT WAS STABLE. THE SYSTEM WAS REPAIRED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12819311 ↗
• InjuryOct 1, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  THE DOC HOLSTER CAME OFF OF TABLE CLAMP AND THE WASHERS INSIDE SHORTED OUT THE CIRCUIT CAUSING THE PLASTIC TO MELT. NO PATIENT WAS INVOLVED IN THIS EVENT AND NO ADVERSE CONSEQUENCES OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 10616201 ↗
• MalfunctionNov 15, 2019Smoking; Smoking

  AFTER A POWER SURGE IN THE HOSPITAL, AN AUDIBLE "BANG" OCCURRED AND SMOKE WAS NOTED TO BE COMING FROM THE SYSTEM. THERE WAS INTERMITTENT ANGIO CO-REGISTRATION FEED RESULTING IN GRAINY IMAGES BEING DISPLAYED. THE HOSPITAL EXPERIENCED A POWER SURGE AND THE SYSTEM BECAME UNABLE TO FUNCTION PROPERLY. THE FUSES WERE REPLACED AND THE KIT WAS ATTEMPTED TO BE BOOTED, BUT AN AUDIBLE "BANG" OCCURRED AND THE SYSTEM WOULD NO LONGER POWER UP. SMOKE WAS NOTED TO BE COMING FROM THE SYSTEM. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. AFTER INVESTIGATION, THE POWER SUPPLY UNIT FUSES WERE FOUND TO BE BLOWN. THE FUSES WERE REPLACED AND THE ISSUE WAS RESOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9328659 ↗
• InjuryApr 24, 2019Connection Problem; Connection Problem

  THE PROCEDURE WAS POSTPONED DUE TO A CONNECTION ISSUE THAT OCCURRED AFTER A CATHETER WAS DISCONNECTED WITHOUT USING THE EJECT BUTTON. ANOTHER CATHETER WAS USED BUT THE ISSUE PERSISTED. THE ISSUE WAS ISOLATED TO THE SYSTEM. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546870 ↗
• InjuryNov 6, 2018Signal Artifact/Noise; Erratic or Intermittent Display; Signal Artifact/Noise; Erratic or Intermittent Display

  A DRAGONFLY OPTIS CATHETER WAS ADVANCED TO THE LESION, BUT WHEN IN LIVE VIEW, THE VIBRATION FROM THE DEVICE WAS SIGNIFICANT. A "PINCH TEST" WAS PERFORMED WHICH SHOWED ARTIFACTS. WHEN A PULLBACK WAS PERFORMED, THE OPTIS INTEGRATED SYSTEM FAILED TO ACQUIRE AN IMAGE. AFTER TWO ATTEMPTS, A SECOND DRAGONFLY OPTIS CATHETER WAS PREPARED. AFTER A PULLBACK WAS PERFORMED WITH THIS DEVICE, THE SYSTEM WAS NOT ABLE TO ACQUIRE AN IMAGE EITHER. THE PROCEDURE WAS RESCHEDULED AND COMPLETED ON (B)(6) 2018 WITH NO ISSUES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8042682 ↗