PULSAR®II PS100-100RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169078406), received between Jan 13, 2020 and Nov 8, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (2 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2023Activation Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT WHEN THE DOCTOR USED THE HANDPIECE FOR ABOUT 5 MINUTES, THEY NOTICED IT WOULD SOMETIMES OUTPUT CUT WHEN USING COAG. THEY RECONNECTED THE BLADE BUT IT PERSISTED. AFTER SWITCHING TO A NEW HANDPIECE, THE SAME ISSUE OCCURRED. THE DOCTOR CAREFULLY USED THE HANDPIECE TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THIS OCCURRED DURING A MASTECTOMY AND THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093708 ↗
• InjuryJan 11, 2021Material Separation; Device Damaged Prior to Use; Material Separation; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT DURING A PROCEDURE A PIECE OF THE HANDPIECE BEING USED CAME FREE OF THE TIP AND BURNED THE PATIENT. THE BURN WAS FULL THICKNESS, AND THE CHAR NEEDED TO BE EXCISED AND THREE SEPARATE AREAS WERE STITCHED AS A RESULT OF THIS INCIDENT. THE SUTURES NEEDED TO BE REVISED AND RE-STITCHED. IT WAS ALSO NOTED THAT THEY WERE UNABLE TO USE THE USB PORT. 5-10 MINUTES OF DELAY WHILE THE WOUNDS WERE INVESTIGATED PLUS ADDITIONAL TIME TO REVISE. IT WAS STATED THAT THERE WAS NO IMPACT TO THE PATIENT OUTCOME.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 11147989 ↗
• MalfunctionJan 13, 2020Activation Problem; Activation Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THE GENERATOR WAS STILL IN USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9583471 ↗