PhotonGuide AdaptRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00816728021315), received between Jan 5, 2023 and Sep 22, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861937 ↗
• MalfunctionSep 22, 2026Overheating of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861528 ↗
• MalfunctionNov 29, 2023Melted; Overheating of Device; Smoking; Melted; Overheating of Device; Smoking

  PER THE CUSTOMER, THE DEVICE MELTED AND SMOKED WHILE IN USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18226959 ↗
• InjuryJan 5, 2023Overheating of Device; Overheating of Device

  PER THE CUSTOMER, THE DEVICE BURNED A PATIENT DURING A PROCEDURE. THE PATIENT REQUIRED FURTHER RECONSTRUCTIVE SURGERY TO REPAIR BURNED SKIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

  Patient problems: Burn(s)

  MAUDE report 16101609 ↗