PlasmaBlade(TM) PS210-030PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169617131), received between Jan 13, 2021 and Nov 29, 2021 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fire” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2021Melted; Melted

  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 10 MINUTES, HE FOUND THAT THE PLASTIC FILM ON THE TIP OF THE HANDPIECE HAS MELTED, SO THE DOCTOR REPLACED THE HANDPIECE TO COMPLETE THE OPERATION. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883351 ↗
• MalfunctionNov 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPENED, IT WAS FOUND THAT THE SUCTION FELL OFF, THE HANDPIECE WAS COMPLETELY NEW, SO THE DOCTOR REPLACED WITH A NEW HANDPIECE TO PREFORM THE OPERATION. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883240 ↗
• MalfunctionJun 7, 2021Fire; Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT WHEN THE DOCTOR USED THE HANDPIECE AT THE BEGINNING OF THE OPERATION, HE FOUND SPARKS FROM THE HANDPIECE TIP. THE DOCTOR TRIED TO ADJUST THE ENERGY TO AVOID SPARKS, BUT AFTER SEVERAL TESTS, THERE WERE STILL SPARKS ON THE TIP OF THE HANDPIECE TIP. FINALLY, THE DOCTOR REPLACED A NEW HANDPIECE TO COMPLETE THE OPERATION. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11946718 ↗
• MalfunctionFeb 12, 2021Fire; Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT WHEN THE DOCTOR USED THE HANDPIECE AT THE BEGINNING OF THE OPERATION, HE FOUND SPARKS FROM THE HANDPIECE TIP. THE DOCTOR TRIED TO ADJUST THE ENERGY TO AVOID SPARKS, BUT AFTER SEVERAL TESTS, THERE WERE STILL SPARKS ON THE TIP OFF THE HANDPIECE TIP. FINALLY, THE DOCTOR REPLACED TO A NEW HANDPIECE TO COMPLETE THE OPERATION. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11322776 ↗
• MalfunctionJan 13, 2021Melted; Melted

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT WHEN THE DOCTOR USED THE HANDPIECE FOR ABOUT 30 MINUTES, HE FOUND THAT THE PLASTIC FILM ON THE TIP OF THE HANDPIECE HAD MELTED, SO THE DOCTOR REPLACED A HANDPIECE TO COMPLETE THE OPERATION. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11164468 ↗