PlasmaBlade(TM) PS210-030SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169617148), received between Jun 29, 2018 and Oct 21, 2021 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Arcing of Electrodes” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2021Fire; Arcing of Electrodes; Fire; Arcing of Electrodes

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A GENERATOR. IT WAS REPORTED THAT THE HANDPIECE MADE AN ARCHING AND FLAMING FROM THE TIP OF THE BLADE ( THE SET UP WAS 6-6). THE DOCTOR DECIDED NOT TO USE THE HANDPIECE, REQUESTED FOR A REGULAR CAUTERY AS SHE WAS ALMOST DONE DISSECTING THE BREAST. A NEW CAUTERY MACHINE WAS WHEELED IN TO THE ROOM, NEW CAUTERY PENCIL OPENED. THE DEFECTIVE HANDPIECE WAS REMOVED FROM THE FIELD, CLEANED WITH ISOWIPE. NO HARM OR BURN ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673129 ↗
• MalfunctionJul 30, 2021No Device Output; Device Damaged Prior to Use; No Device Output; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING TWO HANDPIECES. IT WAS REPORTED THAT WHEN THEY WE WENT TO USE A HANDPIECE AND WHEN WAS TAKING IT OUT OF ITS BOX, THEY FOUND IT WASN¿T SEALED SO THEY OPENED A SECOND ONE TO ALSO FIND THAT ONE WAS ALSO NOT SEALED, THEREFORE BOTH PRODUCTS WERE NOT STERILE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252583 ↗
• MalfunctionJul 30, 2021No Device Output; Device Damaged Prior to Use; No Device Output; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING TWO HANDPIECES. IT WAS REPORTED THAT WHEN THEY WE WENT TO USE A HANDPIECE AND WHEN WAS TAKING IT OUT OF ITS BOX, THEY FOUND IT WASN¿T SEALED SO THEY OPENED A SECOND ONE TO ALSO FIND THAT ONE WAS ALSO NOT SEALED, THEREFORE BOTH PRODUCTS WERE NOT STERILE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252580 ↗
• InjuryMar 24, 2021Arcing of Electrodes; Arcing of Electrodes

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT DURING A BATTERY REPLACEMENT, THE PATIENT EXPERIENCED ONE BIG ELECTRICAL SHOCK THAT WENT TO THE OPPOSITE RIGHT ARM AND HAND AND ALSO TO UPPER LEG AND LOWER LEG. NOT THE FOOT AT ALL. IT WAS NOTED THAT THE PATIENT DID FEEL NUMBNESS IN THE RIGHT ARM AND LEG FOR 5 MINUTES. IT WENT AWAY AFTER 10 MINUTES TOTALLY. IT WAS FURTHER STATED THAT THE HANDPIECE TIP DID TOUCH ACCIDENTLY THE IMPLANTABLE NEUROSTIMULATOR WHEN THE NEUROSURGEON WAS DISSECTING IN THE UPPER PART OF THE POCKET. THE NEUROSURGEON DID STOP TO USE THE GENERATOR AND THE HANDPIECE IMMEDIATELY. THE DOCTOR DID MEASURE POST-OPERATIVE ELECTRODE IMPEDANCE AND THERAPY IMPEDANCE. THEY WERE ALL WITH IN THE SAME RANGE AS BEFORE THE BATTERY REPLACEMENT. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME

  Patient problems: Electric Shock; Numbness

  MAUDE report 11563570 ↗
• MalfunctionMar 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT THE SURGEON WAS USING THE HANDPIECE DURING A SURGICAL PROCEDURE AND THE BLACK PROTECTIVE SHIELD AT THE TIP OF THE HAND PIECE FELL-OFF. A NEW HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543629 ↗
• InjuryOct 9, 2020Arcing of Electrodes; Arcing of Electrodes

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A GENERATOR AND HANDPIECE. IT WAS REPORTED THAT THE GENERATOR WAS TURNED ON AND SELF-CHECK WAS NORMAL. THE HANDPIECE WAS ATTACHED TO THE GENERATOR. THE SMOKE EVACUATOR ACTIVATOR WAS PUT VERY CLOSE ON THE HANDLE CONTACT. THE SETTINGS WERE PUT TO CUT 5 AND COAG 6. UPON ACTIVATION OF THE HANDLE COAG, THE GENERATOR ALARM WENT ON WITH A RED LIGHT SQUARE AND ALARM NOISE DUE TO LACK OF PATIENT RETURN ELECTRODE. A PATIENT RETURN ELECTRODE WAS ATTACHED ON THE PATIENTS RIGHT UPPER THIGH TOP. GREEN LIGHT (SQUARE) TURNED UP. THE HCP ACTIVATED THE COAG AGAIN AND PERFORMED COAGULATION AND THEN CUT TO DISSECT THEIR WAY DOWN TO THE DBS-BATTERY CAPSULA/BATTERY POCKET. THE DBS-BATTERY POCKET WAS CLOSED BY THE LAST LAYER OF FIBROTIC TISSUE WHEN THE EVENT OCCURRED. THE HCP WAS USING THE HANDLE CUT 5 WHEN TRYING TO DISSECT THE LAST LAYER OF THE FIBROTIC CAPULA AROUND AN ALMOST TOTALLY DEPLETED INTERNAL NEUROSTIMULATOR. SUDDENLY THE PATIENT RECEIVED A HEAVY ELECTRICAL SHOCK ON THE RIGHT PART OF THE BODY, WITH HEAVY MUSCLE CONTRACTIONS FROM HEAD TO ALL 5 TOES. HEAVY SYMPTOMS OF MUSCULAR CONTRACTIONS ON RIGHT SIDE OF THE BODY WERE REP

  Patient problems: Dysphasia; Electric Shock; Muscle Spasm(s); Muscular Tics

  MAUDE report 10659623 ↗
• MalfunctionSep 15, 2020Peeled/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 IN A CLINICAL CASE TODAY HE OBSERVED THE HEAT SHRINK WAS DAMAGED AND PEELING OFF. THE SITE FINISHED THE CASE WITH THE SAME HANDPIECE WITH NO NEGATIVE IMPACT TO THE PATIENT. IT WAS NOTED THAT THIS WAS NOT A GENERATOR ISSUE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10538381 ↗
• MalfunctionApr 1, 2020Fire; Melted; Fire; Melted

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A GENERATOR AND A HANDPIECE. IT WAS REPORTED THAT THEY HAD AN ISSUE WITH A PLASMA BLADE DURING A CLINICAL CASE. IT WAS STATED THAT THE "TIP STARTED ON FIRE, PATIENT NOT AFFECTED¿. NO INJURY TO PATIENT WAS REPORTED, AND THE PLASMA BLADE WAS REPLACED IMMEDIATELY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9911030 ↗
• MalfunctionJun 29, 2018Fire; Fire

  DURING A BREAST ONCOLOGY CASE, THE CLEAR PLASTIC BELOW THE PLASMABLADE DEVICE TIP SPLIT AND WHEN STAFF TESTED THE DEVICE IN THE AIR, THE TIP CAUGHT ON FIRE AND HAD TO BE PUT OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7651137 ↗