PULSAR®II PS100-102RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169078444), received between Apr 1, 2020 and Nov 21, 2022 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT THE "PATIENT WAS BURN ON THE CHEEK."

  Patient problems: Burn(s)

  MAUDE report 15835570 ↗
• MalfunctionApr 1, 2020Fire; Melted; Fire; Melted

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT THEY HAD AN ISSUE WITH A PLASMA BLADE DURING A CLINICAL CASE. IT WAS STATED THAT THE "TIP STARTED ON FIRE, PATIENT NOT AFFECTED¿. NO INJURY TO PATIENT WAS REPORTED, AND THE PLASMA BLADE WAS REPLACED IMMEDIATELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911006 ↗