PlasmaBlade™ X PS210-030S (UDI 00763000059811)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00763000059811), received between Jul 24, 2020 and Sep 10, 2026 — classified as 2 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Fire” (10 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 25 most recent of 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Fire

  THE PLASMA BLADE CAUGHT FIRE. THE EQUIPMENT WAS NOT TOUCHING THE PATIENT WHEN THIS HAPPENED. NO HARM TO PATIENT IN ANYWAY. FLUIDS WERE ON THE FIELD AND THE FIRE WAS IMMEDIATELY PUT OUT. LOT#211006 EXP:10-31-2028 REFERENCE# PS210-030S.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50713860 ↗
• MalfunctionDec 26, 2025Fire; Fire

  INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING A HANDPIECE. IT WAS REPORTED THAT DURING A PROCEDURE THE SPARKS WERE OBSERVED COMING FROM THE TIP OF THE HANDPIECE DURING OPERATION. UPON SEEING THE SPARKS, THE SURGEON CHOSE NOT TO USE THE PRODUCT AND OPENED A NEW PIECE INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894809 ↗
• MalfunctionMay 7, 2025Activation Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A LUMPECTOMY PROCEDURE, THE HANDPIECE WAS UNRESPONSIVE, SWITCHING FROM COAG TO CUT. THE ISSUE OCCURRED INTRAOPERATIVELY, CASE CONTINUED BY OPENING UP ANOTHER HANDPIECE, AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED IMPACT ON PATIENT..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975134 ↗
• MalfunctionApr 30, 2025Activation Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A LUMPECTOMY PROCEDURE, THE HANDPIECE WAS UNRESPONSIVE, SWITCHING FROM COAG TO CUT. THE ISSUE OCCURRED INTRAOPERATIVELY, ANDCASE CONTINUED BY OPENING UP ANOTHER HANDPIECE, AND THE ISSUE WAS RESOLVED. THERE WAS NO REPORTED IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932599 ↗
• MalfunctionFeb 10, 2025Melted; Melted

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A HIP REVISION SURGERY, THE PLASTIC ON THE HANDPIECE WAS MELTED. THE HANDPIECE WAS USED AGAINST METAL, SUCH AS A HEMOSTAT, WHICH WAS LIKELY THE CAUSE OF THE MELTING. ONCE THE ISSUE OCCURRED, THE SURGICAL TEAM SWITCHED TO USING A OTHER HANDPIECE. THE INCIDENT HAPPENED TOWARDS THE END OF THE PROCEDURE, WHICH LASTED ALMOST FOUR HOURS. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR AND WAS NO REPORTED IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343260 ↗
• MalfunctionDec 9, 2024Electromagnetic Interference; Noise, Audible; Electromagnetic Interference; Noise, Audible

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT DURING A SURGERY INVOLVING THE REPLACEMENT OF A DEEP BRAIN STIMULATION DEVICE, A STRANGE SOUND, DESCRIBED AS SIMILAR TO THE NOISE OF A HONEYBEE, WAS EMITTED FROM THE HANDPIECE. THE PATIENT, WHO WAS UNDERGOING THE PROCEDURE UNDER LOCAL ANESTHESIA, REPORTED FEELING CURRENTS IN THE AREA AROUND THE EXISTING DEVICE. THE SETTINGS ON THE GENERATOR WERE CUT 5 AND COAG 6. THE ISSUE WAS OBSERVED INTR A-OPERATIVELY, AND THE SURGEON DECIDED TO STOP USING THE HANDPIECE FOR THE REMAINDER OF THE SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER USE OF THE DEVICE. THE SITE ALSO MENTIONED THAT THEY BELIEVE THE PUMP COVER FIT TOO LOOSELY AND WERE CONCERNED THAT SURFACE DISINFECTANT COULD FLOW INTO THE GENERATOR. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS A DELAY OF AROUND 10 MIN DUE TO THE SOUND CHECK OF THE GENERATOR AND HANDPIECE.

  Patient problems: Electric Shock

  MAUDE report 20878792 ↗
• MalfunctionJul 25, 2024Fire; Fire

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT THERE WERE SPARKS DURING USE. THERE WAS CONFLICTING INFORMATION ON PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS PATIENT INVOLVED AND NO IMPACT ON PATIENT OUTCOME AS THE SITE STOPPED USING THE HANDPIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19828004 ↗
• MalfunctionNov 8, 2023Activation Problem; Activation Problem

  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 5 MINUTES, THEY NOTICED IT WOULD SOMETIMES OUTPUT CUT WHEN USING COAG. THEY RECONNECTED THE BLADE BUT IT PERSISTED. AFTER SWITCHING TO A NEW HANDPIECE, THE SAME ISSUE OCCURRED. THE DOCTOR CAREFULLY USED THE HANDPIECE TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THIS OCCURRED DURING A MASTECTOMY AND THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18093651 ↗
• MalfunctionAug 15, 2023Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT WHILE USING THE HANDPIECE THE SURGEON NOTICED THE POWER DIDN'T TURN OFF AFTER THE BUTTON WAS RELEASED AND THERE WAS STILL ENERGY FLOW WITHOUT PRESSING THE BUTTON. THIS HAPPENED WITH TWO HANDPIECES. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548922 ↗
• MalfunctionAug 15, 2023Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE BLADE COATING FLAKED AWAY FROM THE HANDPIECE TIP. ONLY PARTIAL AMOUNT OF COATING WAS FOUND. IT WAS NOTED THAT THE SITE WAS UNSURE IF ANY COATING WAS LEFT INSIDE THE PATIENT'S BREAST TISSUE AREA. THERE WAS NO DELAY TO THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE ISSUE OCCURRED DURING A MASTECTOMY ON SETTINGS CUT 5 AND COAG 6. IT OCCURRED NEAR THE END OF THE PROCEDURE AND THE PIECE OF THE COATING THAT FLAKED WAS REMOVED FROM THE PATIENT AND IT WAS CONFIRMED THERE WAS NO IMPACT ON THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17548894 ↗
• MalfunctionApr 3, 2023Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A HANDPIECE. IT WAS REPORTED THAT THE INSULATION DISCONNECTED CLOSE TO THE TIP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665828 ↗
• MalfunctionApr 3, 2023Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A HANDPIECE. IT WAS REPORTED THAT THE INSULATION DISCONNECTED CLOSE TO THE TIP. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16665792 ↗
• MalfunctionFeb 17, 2023Fire; Fire

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND HANDPIECES. IT WAS REPORTED THAT THE SITE REPORTED TWO INSTANCES OF SPARKING HANDPIECES DURING THE SAME CASE. THE ACCOUNT ADMITTED TO TOUCHING ANOTHER METAL HANDPIECE FOR THE FIRST INSTANCE OF SPARKS. TO RECTIFY THE SITUATION, THE STAFF REPLACED THE HANDPIECE AND THE GENERATOR. HOWEVER, IT WAS REPORTED THAT THE SECOND HANDPIECE AND SECOND GENERATOR ALSO CAUSED A SPARK WITHOUT TOUCHING ANOTHER METAL OBJECT. THE ORDER IN WHICH THEY WERE USED WAS UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16399049 ↗
• MalfunctionFeb 17, 2023Fire; Fire

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND HANDPIECES. IT WAS REPORTED THAT THE SITE REPORTED TWO INSTANCES OF SPARKING HANDPIECES DURING THE SAME CASE. THE ACCOUNT ADMITTED TO TOUCHING ANOTHER METAL HANDPIECE FOR THE FIRST INSTANCE OF SPARKS. TO RECTIFY THE SITUATION, THE STAFF REPLACED THE HANDPIECE AND THE GENERATOR. HOWEVER, IT WAS REPORTED THAT THE SECOND HANDPIECE AND SECOND GENERATOR ALSO CAUSED A SPARK WITHOUT TOUCHING ANOTHER METAL OBJECT. THE ORDER IN WHICH THEY WERE USED WAS UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397438 ↗
• MalfunctionDec 19, 2022Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT THE COATING WAS PEELING OFF ON THE HANDPIECE. BILATERAL SKIN SPARING MASTECTOMY WAS THE PROCEDURE. THE DEVICE WENT BAD RIGHT AT THE VERY END OF THE PROCEDURE. THE SETTINGS WAS 6 CUT AND 10 COAG. THERE WAS NO IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004328 ↗
• MalfunctionDec 19, 2022Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT THE COATING WAS PEELING OFF ON THE BLADE. BILATERAL NIPPLE SPARING MASTECTOMY WAS THE PROCEDURE. THE DEVICE WENT BAD ON THE LEFT BREAST. THEY OPENED SECOND DEVICE TO FINISH SURGERY AND THEY USED A GREEN-BLUE SURGICAL TOWEL TO CLEAN THE DEVICE. SETTINGS WAS 6 CUT AND 10 COAG. THERE WAS NO IMPACT TO THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004268 ↗
• MalfunctionAug 11, 2022Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A HANDPIECE. IT WAS REPORTED THAT THERE WAS A BENT PLASMA BLADE HANDPIECE. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209761 ↗
• MalfunctionMay 31, 2022Activation Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT THE HANDPIECE WAS CUTTING WHEN COAG WAS ACTIVATED AND COAG WHEN CUT WAS ACTIVATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14547748 ↗
• MalfunctionMar 26, 2022Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR AND A HANDPIECE BEING USED FOR A SCOLI-DEFORMITY PROCEDURE. IT WAS REPORTED THAT THE TIP OF THE HANDPIECE STARTED TO PEEL BACK AND FRAY. IT WAS NOTED THAT THE SURGEON TRIED TO SCRAPE THE TIP IN THE HOLSTER WHICH WAS WHEN THE FRAYING WAS NOTICED. THERE WAS NO DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13920382 ↗
• MalfunctionMar 7, 2022Fire; Fire

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT FEW WEEKS PRIOR, THE DOCTOR EXPLAINED DURING A CASE, THEY HAD TO USE MULTIPLE HANDPIECES. IT WAS STATED THAT THE HANDPIECE WAS SPARKING DURING THE CASE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685195 ↗
• MalfunctionFeb 23, 2022Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585299 ↗
• MalfunctionFeb 7, 2022Melted; Melted

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A HANDPIECE. IT WAS REPORTED THAT THE HANDPIECE SHEATH WAS COMING OFF OF THE TIP OF THE BLADE WHICH CAUSE A DEVIATION. A DIFFERENT HANDPIECE WAS USED TO COMPLETE THE CASE. THERE WAS NO IMPACT TO PATIENT OUTCOME. HALF HOUR DELAY TO CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472323 ↗
• MalfunctionSep 20, 2021Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE SITE HAS HAD SOME ISSUES WITH THEIR GENERATOR AND THE PLASMA BLADES (BLADES ARE PEELING). THE SITE WOULD LIKE TO SEND IN THEIR GENERATOR. NO FURTHER INFORMATION PROVIDED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497417 ↗
• MalfunctionSep 20, 2021Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR. IT WAS REPORTED THAT THE SITE HAS HAD SOME ISSUES WITH THEIR GENERATOR AND THE PLASMA BLADES (BLADES ARE PEELING). THE SITE WOULD LIKE TO SEND IN THEIR GENERATOR. NO FURTHER INFORMATION PROVIDED. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12497268 ↗
• MalfunctionJun 18, 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 THE TIP OF THE HANDPIECE WAS SPARKING. A BOVI WAS THEN USED TO COMPLETE THE PROCEDURE. THE HANDPIECE WAS SET TO CUT 6 COAG 8. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12024303 ↗