PlasmaBlade™ X PS210-030S (UDI 00643169936683)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169936683), received between Nov 20, 2020 and Aug 25, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Energy Output 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2026Smoking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50433037 ↗
• MalfunctionFeb 7, 2022Energy Output Problem; Peeled/Delaminated; Energy Output Problem; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND TWO HANDPIECES. IT WAS REPORTED THAT THERE WAS AN ISSUES WITH TWO HANDPIECES THAT WERE NOT WORKING PROPERLY. THE FIRST HANDPIECE WAS NOT CUTTING THE TISSUE, BUT COAG WAS WORKING. IT LOOKED LIKE COATING WAS PEELING OFF. THE SECOND HANDPIECE CUT DIED WITHIN 10 MINUTES OF USE. SURGEON STATED TISSUE WAS FIBROUS. THE CASE WAS COMPLETED WITHOUT INJURY NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472414 ↗
• MalfunctionFeb 7, 2022Energy Output Problem; Peeled/Delaminated; Energy Output Problem; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND TWO HANDPIECES. IT WAS REPORTED THAT THERE WAS AN ISSUES WITH TWO HANDPIECES THAT WERE NOT WORKING PROPERLY. THE FIRST HANDPIECE WAS NOT CUTTING THE TISSUE, BUT COAG WAS WORKING. IT LOOKED LIKE COATING WAS PEELING OFF. THE SECOND HANDPIECE CUT DIED WITHIN 10 MINUTES OF USE. SURGEON STATED TISSUE WAS FIBROUS. THE CASE WAS COMPLETED WITHOUT INJURY NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472402 ↗
• MalfunctionJan 11, 2022Melted; Melted

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE AND A GENERATOR. IT WAS REPORTED THAT DURING A CERVICAL SPINE PROCEDURE, THE HANDPIECE MELTED IN THE SURGEONS HAND DURING A PROCEDURE. ADDITIONAL INFORMATION ALSO STATED THAT THEY REPLACED THE HANDPIECE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13226022 ↗
• MalfunctionNov 24, 2020Fire; Melted; Fire; Melted

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT THE HANDPIECE CAUGHT FIRE AND THE TIP MELTED WHILE THE HANDPIECE WAS BEING USED DURING A CASE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10893112 ↗
• MalfunctionNov 20, 2020Arcing of Electrodes; Arcing of Electrodes

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10873258 ↗