Constellation, ULTRAVIT, Engauge, 27+ 8065752417Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380657524174), received between Nov 8, 2023 and Aug 13, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Failure to Cut

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50236348 ↗
• MalfunctionApr 22, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT CUTS PER MINUTE (CPM) DID NOT INCREASE (CUTTING ISSUE) DURING CALIBRATION FOR SURGERY. NO ISSUE WITH ASPIRATION WAS REPORTED. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED ON SAME DAY, BUT IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT CONTACT WITH THE SUSPECT PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24951690 ↗
• MalfunctionFeb 19, 2026Failure to Cut

  A PHYSICIAN REPORTED THAT PROBE WAS NOT ACTUATE BEFORE SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY, BUT IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385698 ↗
• MalfunctionAug 6, 2025Failure to Cut; Failure to Cut

  A HEALTHCARE PROFESSIONAL REPORTED PROBE CUTTING WAS POOR DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727507 ↗
• MalfunctionJul 18, 2025Complete Blockage; Complete Blockage

  A NURSE REPORTED THAT THE VITRECTOMY PROBE WAS BLOCKED WITH NO NEGATIVE PRESSURE BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22539946 ↗
• MalfunctionNov 8, 2023Failure to Cut; Failure to Cut

  AN OTHER HEALTHCARE PROFESSIONAL REPORTED THAT PROBE COULD NOT CUT DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE NEW PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097948 ↗