PhotonSaber Y Fin TipRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816728020455), received between Dec 20, 2021 and Dec 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2021Overheating of Device

  INVUITY PHOTONSABER Y - HANDHELD ILLUMINATOR WITH ASPIRATION DEVICE WAS CONNECTED PRIOR TO THE START OF THE PROCEDURE. PRODUCT WAS HOLSTERED CORRECTLY, BUT THE PATIENT SUSTAINED A 1 CM BLISTER/BURN TO THE LEFT INNER THIGH. THE AREA THAT HEATED UP TO CAUSE BLISTER IS WHERE THE LIGHT CORD CONNECTS TO THE LIGHTED SUCTION. ANOTHER PHOTONSABER WAS SWAPPED OUT AND USED, SO THE PHOTONSABER THAT CAUSED THE BLISTER WAS NEVER USED DURING THE PROCEDURE. WITH THE DEFECTIVE PHOTONSABER, STAFF WERE UNABLE TO REPLICATE THE CONDITIONS THAT LED TO THE HEATING UP OF THE CONNECTION AT THE BASE OF THE HANDLE TO THE LIGHT CORD. THE LIGHT CORD WAS ALSO PULLED FROM THE PROCEDURE AND CHECKED FOR ANY MALFUNCTION. THE LIGHT CORD WAS NOT FOUND TO HAVE ANY ISSUES. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 13059815 ↗