PlasmaBlade™ PS210-030PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169936669), received between Mar 31, 2023 and Mar 31, 2023 — classified as 1 malfunction.

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

• MalfunctionMar 31, 2023Fire; Fire

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT (B)(6) (AE SALES) CALLED TO REPORT THAT THE SITE REPORTED SPARKING OF A PLASMABLADE DURING A CASE. THE ACCOUNT ADMITS TO TOUCHING ANOTHER METAL HANDPIECE. TO RECTIFY THE SITUATION, THE STAFF REPLACED THE HANDPIECE. WAS NOT BEING USED ON THE PATIENT AT THE TIME OF INCIDENT, BUT THEY WERE IN THE ROOM. (B)(4)/ CASE NUMBER (B)(4) IS CLOSED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656289 ↗