OPTISi™ 1014941Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067036810), received between Dec 3, 2025 and Dec 3, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Emits Odor” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Device Emits Odor; Smoking; Device Emits Odor; Smoking

  IT WAS REPORTED THAT A CONTRAST BAG WAS PLACED ABOVE THE DOC HOLSTER, AND WAS NOT PROPERLY SEALED, WHICH RESULTED IN FLUID LEAKAGE ONTO THE UNIT. BURNING AND SMOKE FROM THE DOC HOLSTER WAS OBSERVED BY THE STAFF. THE SYSTEM WAS IMMEDIATELY DISCONNECTED WITH THE ASSISTANCE OF THE HOSPITAL¿S BIOMEDICAL ENGINEERING TEAM TO PREVENT FURTHER RISK. THERE WAS NO PATIENT INVOLVEMENT. FIELD SERVICE WAS COMPLETED, AND THE DOC HOLSTER WAS REPLACED TO RESOLVE THE ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706974 ↗