Fiber Dust PFMS00005Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08059173391783), received between Feb 10, 2022 and Nov 24, 2022 — classified as 6 malfunctions.

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

• MalfunctionNov 24, 2022Computer Software Problem; Computer Software Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15860269 ↗
• MalfunctionNov 24, 2022Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE DEVICE HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15860244 ↗
• MalfunctionOct 21, 2022Optical Problem; Optical Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15649167 ↗
• MalfunctionMay 19, 2022Defective Device

  DEVICE NOT WORKING, NOT POSSIBLE TO PERFORM SURGERY. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14446858 ↗
• MalfunctionMay 12, 2022Output Problem; Output Problem

  THE LASER SYSTEM HAD A FAILURE THAT DIDN'T ALLOW TO USE IT. NO ADVERSE EFFECTS TO PATIENT/OPERATOR WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14367704 ↗
• MalfunctionFeb 10, 2022Energy Output Problem; Energy Output Problem

  THE LASER SYSTEM HAD A FAILURE THAT DID NOT ALLOW TO USE IT PROPERLY. NO ADVERSE EFFECTS TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13505537 ↗