CONSTELLATION® HYPERVIT® ENGAUGE® 8065830022Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380658300227), received between Apr 9, 2021 and Apr 19, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2021Failure to Cut; Failure to Cut

  A CUSTOMER REPORTED THAT ACTUATION FAILURE OF A PROBE OCCURRED AND THE CUT RATE DID NOT RISE UP TO 20000 DURING SURGERY. ASPIRATION WAS UNKNOWN. THE PROBE WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683927 ↗
• MalfunctionApr 9, 2021Failure to Cut; Noise, Audible; Failure to Cut; Noise, Audible

  A CUSTOMER REPORTED THAT THE PROBE GENERATED AN ABNORMAL SOUND AND CUTTING/ACTUATION FAILED DURING A PROCEDURE. THE CONDITION OF ASPIRATION IS UNKNOWN. THE PRODUCT WAS REPLACED AND PROCEDURE COMPLETED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11643305 ↗