PlasmaBlade™ X PS210-030S-LIGHT (UDI 00763000279189)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000279189), received between Nov 25, 2020 and May 25, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Shut Off” (4 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.

• MalfunctionMay 25, 2026Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT ONCE THE COAG BUTTON OF THE HANDPIECE WAS DEPRESSED, THE ENERGY CONTINUED TO RUN AS THE BUTTON WAS STUCK IN THE ON POSITION. A PATIENT WAS INVOLVED BUT THERE WAS NO IMPACT ON THE PATIENT OUTCOME. THERE WAS NO DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25268234 ↗
• MalfunctionFeb 7, 2024Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM AN MANUFACTURER REPRESENTATIVE (REP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE ENERGY WAS NOT SHUTTING OFF AFTER THE BUTTON WAS PRESSED. THE COAG BUTTON WAS STICKING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660056 ↗
• MalfunctionOct 25, 2022No Device Output; Peeled/Delaminated; No Device Output; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT THE COATING ON THE END OF THE HANDPIECE PEELED OFF. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667431 ↗
• MalfunctionFeb 21, 2022Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT TIP OF THE HANDPIECE WAS PEELING OFF ABRUPTLY DURING A CASE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13568319 ↗
• MalfunctionJan 12, 2021Energy Output Problem; Failure to Shut Off; Energy Output Problem; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND HANDPIECES. IT WAS REPORTED THAT TA HANDPIECE MALFUNCTIONED DURING A CATH LAB ON THE DAY OF THE CALL. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP AND IT WAS FURTHER STATED THAT THE HAND PIECE CONTINUED TO PRODUCE POWER EVEN AFTER SURGEON STOPPED PRESSING BUTTON. A NEW HAND PIECE WAS OPENED AND THE ISSUE RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11156189 ↗
• MalfunctionNov 25, 2020Failure to Shut Off; Noise, Audible; Failure to Shut Off; Noise, Audible

  INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE SITE HAD A COUPLE HANDPIECES THAT HAD AN ISSUE WHERE THE TONE AND BLADE CONTINUED AFTER THE SURGEON HAD STOPPED PRESSING THE BUTTON. IT WAS CLARIFIED THAT THE HANDPIECES WERE LIGHTED AND CONTINUED TO PRODUCE POWER AND NOISE AFTER THE SURGEON HAD REMOVED THEIR FINGER FROM THE BUTTON. THERE GENERATOR WAS STILL IN USE AND THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10906972 ↗