PlasmaBlade™ X PS210-030S-LIGHT (UDI 00763000279172)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000279172), received between Jul 24, 2020 and Jun 25, 2021 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2021Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A HANDPIECE. IT WAS REPORTED THAT DURING THE USE WITH THE LIGHTED HANDPIECE, THE COATING PEELED OFF, ALMOST SPLITTING IN HALF AS OBSERVED IN ATTACHED PHOTOS. THEY NEVER USED A SCRATCH PAD TO CLEAN HANDPIECE TIP. THIS SURGEON ROUTINELY USED THE OLD HANDPIECE AND THIS WAS HIS FIRST TIME USING THE NEW LIGHTED ONE AND HE WAS JUST DOING ROUTINE DISSECTION AS HE USUALLY DOES AND THIS HAPPENED. THEY IMMEDIATELY OPENED A SECOND ONE AND HAD NO ISSUES WITH SECOND ONE THAT WAS OPENED. THERE WAS NO IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12066964 ↗
• MalfunctionMar 15, 2021No Device Output; Failure to Shut Off; No Device Output; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT THE CUT AND COAGULATION BUTTON WERE CONTINUING TO RUN WITHOUT BEING PRESSED. THEY SWAPPED GENERATOR AND IT WAS AN OUT OF BOX FAILURE. THERE WAS A DELAY OF LESS THAN AN HOUR. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11486224 ↗
• MalfunctionFeb 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND TWO HANDPIECES. IT WAS REPORTED THAT THE COATING ON THE TIP OF TWO HANDPIECES UNITS CAME OFF DURING A PROCEDURE. THEY PULLED A THIRD HANDPIECE AND THEY WERE ABLE TO FINISH THE PROCEDURE. LESS THAN 5 MINUTE DELAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366274 ↗
• MalfunctionFeb 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND TWO HANDPIECES. IT WAS REPORTED THAT THE COATING ON THE TIP OF TWO HANDPIECES UNITS CAME OFF DURING A PROCEDURE. THEY PULLED A THIRD HANDPIECE AND THEY WERE ABLE TO FINISH THE PROCEDURE. LESS THAN 5 MINUTE DELAY. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11366272 ↗
• MalfunctionJan 29, 2021Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT AFTER THE CASE, THE DOCTOR NOTED PEELING OF THE COATING OF THE BLADE AT THE DISTAL TIP. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11253199 ↗
• MalfunctionJan 19, 2021Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT DURING A CASE, THE LIGHTED PLASMA BLADE HANDPIECE MALFUNCTIONED. IT WAS STATED THAT THE HANDPIECE HAD CONTINUOUS POWER WHEN NEITHER THE CUT NOR COAG WAS ACTIVATED ON THE HANDPIECE SWITCH. IT WAS ALSO STATED THAT THIS HAPPENED WHILE HE WAS OPENING UP THE POCKET. THE HANDPIECE WAS DISCARDED BY THE SITE. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11194006 ↗
• MalfunctionSep 22, 2020Failure to Shut Off; Failure to Shut Off

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR AND HANDPIECE BEING USED FOR A BREAST RECONSTRUCTION SURGERY. IT WAS REPORTED THAT THE SURGEON'S ARM LEANED UP AGAINST THE HANDPIECE WHILE IT WAS NOT IN ACTIVE USE AND IT BURNT THEIR ARM. THE HCP HAD SET THE HANDPIECE DOWN ON THE PATIENTS STOMACH AREA AND THEN THEY LEANED TOO CLOSE TO THE BLADE IT BURNED THEIR FOREARM. THE DEVICE BUTTONS WERE NOT ACTIVATED WHEN THE EVENT OCCURRED. IT WAS NOTED THAT THE HCP HAD TOUCHED THE BLADE 3 TO 4 SECONDS AFTER USING IT. THE BURN RESULTED IN A SMALL BLISTER, BUT DID NOT REQUIRE TREATMENT. THE HCP HAD TO BREAK SCRUB TO CLEAN IT AND RE-SCRUB IN TO FINISH THE CASE. THE HCP FELT THE BLADE SHOULD NOT HAVE STILL BEEN HOT SINCE THE LAST USE OF IT. THERE WAS NO DAMAGE TO THE HANDPIECE AND IT WAS NOTED THAT THE SMOKE EVACUATION TUBING WAS IN PLACE BEFORE AND AFTER THE EVENT. THE HANDPIECE WAS USED FOR THE REMAINDER OF THE CASE WITH NO FURTHER ISSUES. THERE WAS A LESS THAN HOUR SURGICAL DELAY AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: Burn(s)

  MAUDE report 10565477 ↗
• MalfunctionSep 15, 2020Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND HANDPIECES. IT WAS REPORTED THAT WHILE TESTING THE NEW PLASMABLADE X LIGHT WITH HIS OWN SYSTEM USING CHICKEN, "HE USED THE DEVICE ON A CHICKEN BREAST, SETTINGS WERE CUT 6, COAG 7. HE HAD IT ACTIVATED FOR ~15 SECONDS AND STATED HE NOTICED IT HAPPEN MORE THE DEEPER HE WENT." "IF YOU LOOK CLOSELY, IT LOOKED LIKE THE RAW METAL BLADE WAS EXPOSED AT THE TIP¿. ADDITIONAL INFORMATION FROM TECHNICAL SERVICES SEEMED TO SHOW THAT BOTH THE COATING ON THE BLADE AND THE HEAT SHRINK HAD SUSTAINED SOME DAMAGE. THE HEATSHRINK HAD A PIECE MISSING. THE INCIDENT WAS A FAULTY HAND PIECE, NOT THE GENERATOR, SO THE GENERATOR WAS STILL IN USE. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10538432 ↗
• MalfunctionSep 15, 2020Peeled/Delaminated; Material Separation; Peeled/Delaminated; Material Separation

  INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND HANDPIECES. IT WAS REPORTED THAT WHILE TESTING THE NEW PLASMABLADE X LIGHT WITH HIS OWN SYSTEM USING CHICKEN, "HE USED THE DEVICE ON A CHICKEN BREAST, SETTINGS WERE CUT 6, COAG 7. HE HAD IT ACTIVATED FOR ~15 SECONDS AND STATED HE NOTICED IT HAPPEN MORE THE DEEPER HE WENT." "IF YOU LOOK CLOSELY, IT LOOKED LIKE THE RAW METAL BLADE WAS EXPOSED AT THE TIP¿. ADDITIONAL INFORMATION FROM TECHNICAL SERVICES SEEMED TO SHOW THAT BOTH THE COATING ON THE BLADE AND THE HEAT SHRINK HAD SUSTAINED SOME DAMAGE. THE HEATSHRINK HAD A PIECE MISSING. THE INCIDENT WAS A FAULTY HAND PIECE, NOT THE GENERATOR, SO THE GENERATOR WAS STILL IN USE. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10538426 ↗
• MalfunctionJul 24, 2020Peeled/Delaminated; Peeled/Delaminated

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A HANDPIECE. IT WAS REPORTED THAT THE TEFLON COATING CAME OFF THE HANDPIECE. THE HANDPIECE WAS BEING USED TO DISSECT AND COAGULATE TISSUE. THE CASE WAS COMPLETED BY OPENING A NEW HANDPIECE THAT WORKED FINE. IT WAS NOTED THAT THE GENERATOR WAS STILL IN USE. ADDITIONALLY, IT WAS THE DOCTOR FIRST AND ONLY TIME USING IT. THE REP DID NOT KNOW IF THE HANDPIECE WAS BENT. THE REP NOTED THE DOCTOR ONLY USED IT TO DISSECT AND SPOT COAG. HE DID NOT USE THE PICK-UPS. THERE WAS NO VISIBLE RESIDUE LEFT IN THE PATIENT. HE HAD BEEN A USER FOR QUITE A WHILE AND ONLY USES WET LAP TO CLEAN. THE STAFF AT THE FACILITY HAS BEEN TRAINED TO DO THAT OFTEN. THEY DID NOT REPORT ANY UNUSUAL BUILD UP ON THE DEVICE.THERE WAS NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10319196 ↗