PlasmaBlade™ X PS210-030S-LIGHT (UDI 00763000279165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00763000279165), received between Mar 15, 2022 and Jun 8, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Failure to Shut Off” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2026Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT THE PROTECTIVE POLYETHYLENE COATING AROUND LEAD OF THE HANDPIECE WAS DAMAGED DURING A GENERATOR CHANGEOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25425064 ↗
• MalfunctionMay 27, 2026Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT DURING INTRA-OPERATIVE USE, THE PIECE OF PROTECTIVE SHEATH DETACHED FROM HANDPIECE. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296494 ↗
• MalfunctionMay 19, 2026Electromagnetic Interference

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT WHEN CUT OR COAG ON THE HANDLE OF THE HANDPIECE WAS PRESSED, OTHER DEVICE MAGNETIC BREAKS WOULD LOCK OR UNLOCK. A PATIENT WAS INVOLVED BUT THERE WAS NO KNOWN IMPACT ON THE PATIENT OUTCOME. THERE WAS NO DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25214595 ↗
• MalfunctionApr 6, 2026Fire

  2026-MAR-11 00875614 SAP ECC SERVICE AND REPAIR 000304554782 (HCP): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT, DURING SURGERY, A HANDPIECE PRODUCED SPARKS, AND SPARKS WERE ALSO OBSERVED COMING OUT OF THE GENERATOR. THE ISSUE OCCURRED INTRA-OPERATIVELY, PATIENT WAS INVOLVED BUT NO REPORTED IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796244 ↗
• MalfunctionAug 25, 2025Failure to Shut Off; Activation Problem; Failure to Shut Off; Activation Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A FESS, THE HANDPIECE WAS NOT TURNING OFF WHILE ON COAGULATION MODE, THE TRIGGER WAS RELEASED, BUT THE DEVICE CONTINUED TO ACTIVATE. AS A RESULT, USE OF THE HANDPIECE WAS ABANDONED AND ANOTHER HANDPIECE WAS BROUGHT IN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882236 ↗
• MalfunctionJan 8, 2025Fire; Fire

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A GENERATOR. IT WAS REPORTED THAT WHEN HANDPIECE WAS ACTIVATED THE FIRE WAS COMING OUT OF THE TIP. SITE USED HANDPIECE INTRA-OPERATIVELY FOR A BREAST CASE. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR. ADDITIONAL INFORMATION WAS RECEIVED, SALES REPRESENTATIVE (REP) CONFIRMED THAT THE COMPLAINT WAS ONLY WITH ONE INSTRUMENT AND THE OTHER INSTRUMENT WAS BEING REQUESTED TO REPLACE DUE TO THE FIRE HAPPENED. HOWEVER, SITE PULLED ANOTHER DEVICE TO TEST THE GENERATOR. NO REPORTED IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102790 ↗
• MalfunctionJul 24, 2024Fire; Smoking; Fire; Smoking

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE HANDPIECE CAUGHT ON FIRE DURING A SURGERY. THE SITE NOTICED SMOKE AND SMALL FLAMES COMING FROM THE HANDPIECE. THERE WAS A DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817889 ↗
• MalfunctionJul 5, 2024Output above Specifications; Failure to Shut Off; Output above Specifications; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THA T DURING TWO CASES A GENERATOR WAS USED AND EXCESS POWER WAS DELIVERED TO TWO SEPARATE HANDPIECES AND MAY HAVE RESULTED IN HARM TO THE PATIENTS. THE COAG FUNCTION WAS GETTING "STUCK"; IT STAYED ACTIVE AND DELIVERED POWER EVEN AFTER IT WAS LET GO. THERE WAS NO DELAY OR PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT ONE PATIENT WAS BURNED CLOSE TO THE INCISION AND THE ISSUE OCCURRED DURING A BREAST LUMPECTOMY WITH SENTINEL NODES PROCEDURE AND A EXCISIONAL BIOPSY.

  Patient problems: Burn(s)

  MAUDE report 19681554 ↗
• MalfunctionJul 5, 2024Output above Specifications; Failure to Shut Off; Output above Specifications; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THA T DURING TWO CASES A GENERATOR WAS USED AND EXCESS POWER WAS DELIVERED TO TWO SEPARATE HANDPIECES AND MAY HAVE RESULTED IN HARM TO THE PATIENTS. THE COAG FUNCTION WAS GETTING "STUCK"; IT STAYED ACTIVE AND DELIVERED POWER EVEN AFTER IT WAS LET GO. THERE WAS NO DELAY OR PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT ONE PATIENT WAS BURNED CLOSE TO THE INCISION AND THE ISSUE OCCURRED DURING A BREAST LUMPECTOMY WITH SENTINEL NODES PROCEDURE AND AN EXCISIONAL BIOPSY.

  Patient problems: Burn(s)

  MAUDE report 19681428 ↗
• MalfunctionJun 5, 2024Fire; Overheating of Device; Smoking; Fire; Overheating of Device; Smoking

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR BEING USED FOR A MAS TECTOMY. IT WAS REPORTED THAT ON BEHALF OF SITE THAT DURING A CASE, THE SITE REPORTED THE HANDPIECE "STARTING OVERHEATING AND EMITTING SMOKE AND THEY COULD SEE SMALL FLAMES INSIDE THE DEVICE." THE SITE REPORTED THEY REMOVED INSTRUMENT FROM STERILE FIELD AND CONTINUED WITH CASE. PATIENT WAS PRESENT BUT SITE STATED NO IMPACT TO PATIENT OR STERILE FIELD. THERE WAS A DELAY OF LESS THAN 1 HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468189 ↗
• MalfunctionApr 4, 2024Premature Activation; Premature Activation

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT THE HANDPIECE WOULD START WITHOUT ANYONE TOUCHING THE POWER BUTTON. A NEW HANDPIECE WAS USED TO CONTINUE WITH SURGERY. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19043122 ↗
• MalfunctionMar 22, 2024Melted; Melted

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT  THE TIP OF THE HANDPIECE WAS "MELTING OFF" DURING A CASE. KEVIN SAID THAT THE ACCOUNT HAD DISCARDED THE INSTRUMENT AFTER USE. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961964 ↗
• MalfunctionApr 11, 2023Failure to Shut Off; Unexpected Shutdown; Failure to Shut Off; Unexpected Shutdown

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT ONE OF THE BREAST SURGEONS AT A FACILITY WAS EXPERIENCING A SMALL ISSUE WHEN USING THE HANDPIECE. SPECIFICALLY, AFTER THE COAG BUTTON WAS RELEASED POWER WAS STILL BEING APPLIED TO THE ELECTRODE TIP FOR APPROXIMATELY 3-7 SECONDS. THE SURGEON STATED THAT IN SOME INSTANCES, THE POWER DELIVERY WILL SHUT OFF ON IT'S OWN AFTER A FEW SECONDS OR IN SOME CASES SHE WOULD TOUCH THE ELECTRODE TIP TO A LAP TOWEL OR GAUZE IT THE POWER WOULD STOP FLOWING. THE SURGEON'S CONCERN WAS POTENTIALLY BURNING/CUTTING TISSUE ACCIDENTALLY. SHE ALSO NOTICED IT TENDED TO HAPPEN LONGER INTO THE CASE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16716225 ↗
• MalfunctionJun 30, 2022No Device Output; Failure to Shut Off; No Device Output; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT THAT DUE TO PREVIOUS COMPLAINTS OF THE FOLLOWING ISSUE: REPORTED THAT WHEN LETTING OFF OF THE COAG BUTTON THE HANDPIECE WAS STILL ACTIVE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14880797 ↗
• MalfunctionJun 8, 2022Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT WHEN LETTING OFF OF THE COAG BUTTON THE HANDPIECE WAS STILL ACTIVE. THAT HAS HAPPENED MULTIPLE TIMES. THE HANDPIECE WAS DISCARDED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633179 ↗
• MalfunctionMay 16, 2022Break; No Device Output; Break; No Device Output

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT THE DEVICE WAS TAKEN OUT OF THE PACKAGE ON SURGICAL FIELD. WHEN CORDS WERE SEPARATED AND GREY COVER AROUND PLUG BROKE INTO 2 PIECES BEFORE THEY COULD PLUG IT IN TO GENERATOR. THE PATIENT WAS NOT AFFECTED. THEY OPENED A NEW DEVICE AND IT WORKED GREAT. THEY ONLY HAD ONE HALF OF GREY PLUG COVER AND THE OTHER HALF WAS LOST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14407957 ↗
• MalfunctionMay 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT DURING A PROCEDURE, A HANDPIECE AT THE SITE HAD THE COATING STRIPPING OFF AND THE TIP FELL OFF.  THEY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE INSTEAD. THERE WAS NO IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14346184 ↗
• MalfunctionApr 8, 2022Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT DURING A PROCEDURE, THE HANDPIECE CERAMIC WAS PEELING OFF DURING THE CASE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14052859 ↗
• MalfunctionMar 15, 2022Detachment 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 THE PHYSICIAN WENT TO EXTEND THE TIP AND DID NOT LOOSEN LOCKING MECHANISM SO DURING EXTENSION THE LOCKING MECHANISM MOVED WITH THE SHAFT. PHYSICIAN COULD PUT IT BACK ON THE HANDPIECE. NOT AN OOBF. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13771696 ↗