PlasmaBlade™ X PS200-040 (UDI 00763000059842)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000059842), received between Aug 26, 2020 and Aug 14, 2026 — classified as 2 injuries, 2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Fire

  Information was received from a healthcare provider regarding a handpiece. It was reported that during pacemaker replacement surgery the surgical site was re-prepped with an alcohol-based chlorhexidine solution following patient movement and difficulty securing IV access, which required multiple interventions. A significant amount of the antiseptic solution migrated beneath the surgical drape and saturated the underlying draping material. The handpiece was then activated before the alcohol vapors had fully dissipated, resulting in ignition and a fire beneath the drape. The fire was extinguished within approximately one minute; however, the patient sustained second- and third-degree burns. No product defect was identified.

  Patient problems: Burn(s)

  MAUDE report 50251414 ↗
• MalfunctionJul 18, 2023Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE COATING BEGAN PEELING OFF OF THE HANDPIECE. THE SURGEON SWITCHED TO A DIFFERENT HANDPIECE TO FINISH THE CASE. THE FACILITY DID NOT SAVE THE PACKAGING OR DEVICE. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342439 ↗
• InjuryFeb 23, 2023Electromagnetic Interference; Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT WHILE THE HOSPITAL WAS PERFORMING A BI-VENTRICULAR PPM UPGRADE. IT WAS A COMPLEX CASE AS THEY WERE PUTTING THE LEAD IN THE RIGHT SUBCLAVIAN VEIN, AND THEN TUNNELING ACROSS TO THE LEFT SIDE WHERE THE EXISTING DEVICE WAS ALREADY INSIDE TO ATTACH AND SCREW IN THE LEAD (THE LEFT SUBCLAVIAN VEIN WAS TOO NARROW TO INTRODUCE ANOTHER LEAD). THE PATIENT WAS PACEMAKER DEPENDENT. THEY HAD PERFORMED THE FIRST PART OF THE OPERATION AND HAD MOVED TO THE LEFT SIDE TO ACCESS THE EXISTING DEVICE USING DIATHERMY (PLASMABLADE). THE DOCTOR WAS USING THE CUT FUNCTION (6) AND IT CAUSED INTERFERENCE WITH THE SIGNAL FROM THE PACEMAKER RESULTING IN LOSS OF CAPTURE AND THEREFORE ASYSTOLE.

  Patient problems: Cardiac Arrest

  MAUDE report 16429082 ↗
• MalfunctionAug 26, 2020Fire; Arcing of Electrodes; Fire; Arcing of Electrodes

  2 INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT THE TIP OF THE HANDPIECE BEGAN TO ARCH, SPARK, AND PRODUCE A VISIBLE FLAME DURING A PACEMAKER PROCEDURE. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY OR ADVERSE EVENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CAUTERY TOOL. THE SETTINGS WERE CUT 7 AND COAG 7.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10458013 ↗