NeuroBlate® System 20360 (REF NB102)Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00816589020403), received between May 26, 2017 and Mar 29, 2018 — classified as 11 deaths, 77 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (38 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 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2018Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, RIBBON BLUE PIXELS APPEARED THROUGHOUT TREATMENT. THE USER LET OFF THE FOOT PEDAL UNTIL IT WAS COOLED, THE WATTAGE WAS LOWERED, BUT THE BLUE PIXELS CONTINUED. THERE WERE NO PATIENT COMPLICATION REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7382343 ↗
• MalfunctionNov 16, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, TOWARDS THE END OF THE ABLATION BLUE PIXELS STARTED TO APPEAR IN THE NOISE MASK. THE USER WAS INSTRUCTED TO STOP DELIVERING LASER ENERGY SO THE BLUE PIXELS WOULD DISAPPEAR PER THE NORMAL WORKAROUND FOR THIS ISSUE. HOWEVER, THE BLUE PIXELS DID NOT DISAPPEAR AFTER MORE THAN A MINUTE OF WAITING. THE LASER WAS CONTINUED AND THE BLUE PIXELS WERE NOTED AS ARTIFACT. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036903 ↗
• MalfunctionNov 16, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, COLD PIXELS APPEARED NEAR THE PROBE TIP IN MULTIPLE SLICE PLANES DURING MULTIPLE ABLATIONS. WHEN THE USER RELEASED THE FOOTPEDAL, THE COLD PIXELS PERSISTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036864 ↗
• MalfunctionNov 16, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, COLD PIXELS OCCURRED IMMEDIATELY GOING INTO THE ABLATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036846 ↗
• MalfunctionNov 16, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, PURPLE PIXELS FROM THE BIOPSY SITE AND BLOOD CAUSED ARTIFACT AND DID NOT ALLOW THERMAL DOSE THRESHOLD (TDT) LINES TO SPREAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036841 ↗
• MalfunctionNov 16, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, PURPLE PIXELS FROM THE BIOPSY SITE AND BLOOD CAUSED ARTIFACT AND DID NOT ALLOW THERMAL DOSE THRESHOLD (TDT) LINES TO SPREAD. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7036832 ↗
• MalfunctionOct 31, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, COLD PIXELS APPEARED NEAR THE LASER PROBE DURING INSERTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6990923 ↗
• MalfunctionOct 31, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, BLUE AND PURPLE PIXELS APPEARED ADJACENT TO THE THERMAL DOSE THRESHOLD (TDT) LINES WHERE HEATING SHOULD HAVE EXPANDED; THE PROBE WAS FIRING AT 100% POWER. THE SURGEON ASSUMED THAT THIS AREA WAS PROBABLY HOT. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6990908 ↗
• MalfunctionOct 27, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE BOLT CAUSED PIXEL DROP, DID NOT SHOW THERMAL DOSE THRESHOLD (TDT) LINES, AND SIGNAL LOSS. THE BOLT WAS SAID TO CAUSE ARTIFACT IN THE BRAIN FOR SUPERFICIAL LESIONS. THIS ARTIFACT CAUSED AN ISSUE WITH THE TREATMENT OF THE PATIENT'S LESION DUE TO THE LESION BEING SO SUPERFICIAL, ALONG WITH THE PIXEL DROP AND TDT LINES. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6984227 ↗
• InjuryOct 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ENCEPHALOPATHY WAS NOT RELATED TO THE ABLATION SURGERY.

  Patient problems: Confusion/ Disorientation; Patient Problem/Medical Problem; Seizures

  MAUDE report 6983167 ↗
• MalfunctionOct 25, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, WHILE TREATING, THE USER NOTICED SOME COLD PIXELS NEAR THE PROBE TIP (5-8MM). THE TEMPERATURE VALUE OF THESE PIXELS WAS APPROXIMATELY 28-30 DEGREES CELCIUS. THE USER LET OFF THE FOOT PEDAL WHICH RESULTED IN THE PIXELS DRIFTING BACK TO NORMAL BODY TEMPERATURE WITHIN 2 ACQUISITIONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6978307 ↗
• MalfunctionOct 19, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, THE THERMAL DOSE THRESHOLD (TDT) LINES SHOWED UP IN AN AREA CEREBROSPINAL FLUID AND WERE ALSO INACCURATE AT THE BOTTOM OF THE CENTER SLICE. THIS CREATED THE NEED TO INTERPOLATE THE AREA THAT WAS THOUGHT TO BE TRUE AND DISREGARD THE SUPPOSED INCORRECT TDT LINES. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6962765 ↗
• DeathOct 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED CEREBRAL EDEMA, WAS HYPOTENSIVE, AND HAD A CHEYNE-STOKES BREATHING PATTERN. THE PATIENT WAS PRESCRIBED STEROIDS AND PLACED ON AN EXTERNAL VENTRICULOSTOMY DEVICE (RVD). ULTIMATELY, THE PATIENT DIED.

  Patient problems: Death; Edema

  MAUDE report 6949324 ↗
• InjuryOct 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT HAD SEIZURES SECONDARY TO CEREBRAL EDEMA AND PNEUMOCEPHALUS. THE PATIENT WAS PRESCRIBED STEROIDS AND ANTICONVULSANTS. THE PATIENT WAS THEN DISCHARGED FROM THE HOSPITAL AND TO AN ACUTE CARE HOSPITAL. ULTIMATELY, THE PATIENT EXPIRED FROM HER UNDERLYING DISEASE.

  Patient problems: Edema; No Code Available; Seizures

  MAUDE report 6949323 ↗
• InjuryOct 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED PNEUMONIA, DYSPNEA, HEADACHES, AND ELEVATED BLOOD PRESSURE. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2017 AND PRESCRIBED MEDICATION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017, WITH PNEUMONIA, WHICH WAS CONSIDERED THE EVENT RESOLVE DATE. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Dyspnea; Headache; Pneumonia

  MAUDE report 6912426 ↗
• InjuryOct 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED 3-4 EPISODES OF NON-CONVULSIVE SEIZURES AND TRANSIENT LEFT SIDED WEAKNESS (UPPER EXTREMITY AND LOWER EXTREMITY). THE HOSPITAL COURSE WAS COMPLICATED BY DIABETIC KETOACIDOSIS (DKA) AND A CLOSTRIDIUM DIFFICILE (C. DIFF) INFECTION, INCREASED PSYCHOSIS AND PARANOIA, AS WELL AS EPISODES OF UNRESPONSIVENESS AND STARING SPELLS IN HOSPITAL WITH UNKNOWN ETIOLOGY. THE PATIENT WAS HOSPITALIZED AND RECEIVED STEROIDS AND ANTICONVULSANTS. IT WAS NOTED THAT THE PATIENT'S DKA WAS A RESULT OF THE PATIENT'S POORLY CONTROLLED TYPE 2 DIABETES WHICH WAS THEN FURTHER COMPLICATED BY THE HIGH DOSE STEROIDS SHE WAS ON DURING THE HOSPITALIZATION. THE C. DIFF INFECTION HAD UNCLEAR ETIOLOGY, BUT WAS ACQUIRED WHILE ADMITTED IN THE HOSPITAL FOR THE ADVERSE EVENT. THE PATIENT ALSO HAD AN ELECTROENCEPHALOGRAM AND AN ELECTROCARDIOGRAPHY PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND INTO HOSPICE ON (B)(6) 2017. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Emotional Changes; Seizures; Unspecified Infection; Weakness

  MAUDE report 6912414 ↗
• MalfunctionSep 29, 2017Device Operational Issue; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, COLD PIXELS APPEARED IN A BOW TIE FORMATION WHEN USING A PROBE AT 78% LASER POWER. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6903379 ↗
• InjurySep 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE INTRAPARENCHYMAL HEMORRHAGE OCCURRED DUE TO A PREVIOUS PROCEDURE (STEREO EEG ELECTRODE PLACEMENT).

  Patient problems: Headache; Hemorrhage/Blood Loss/Bleeding; Weakness

  MAUDE report 6899643 ↗
• InjurySep 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED MULTIPLE STROKES, A PULMONARY EMBOLISM, AND BECAME HEMIPLEGIC. THE PATIENT WAS ON A HEPARIN DRIP AND WAS GOING TO A REHABILITATION FACILITY. IT WAS NOTED THAT THE STROKE LOCATIONS WERE NOT IN CONTACT WITH THE ABLATED TERRITORY. THE PATIENT WAS CONSIDERED STABLE BUT HEMIPLEGIC. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Paralysis; Pulmonary Embolism; Stroke/CVA

  MAUDE report 6899626 ↗
• MalfunctionSep 26, 2017Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING THE TRAINING OF A NEW SURGEON, THE CONNECTOR MODULE (CM) MELTED AT THE CONNECTION TO THE TEST LASER. IT WAS NOTED THAT THE MONTERIS REPRESENTATIVE DID NOT CLICK IN THE LASER FIBER TWICE, AND THAT AFTER FIRING FOR A FEW MINUTES, IT WAS REALIZED WHAT HAPPENED. THE BACKUP CM WAS SWAPPED TO COMPLETE THE TRAINING. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6896448 ↗
• InjurySep 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE THE PATIENT EXPERIENCED LEFT SIDED WEAKNESS AND INSTABILITY. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED A FALL 2 DAYS AFTER DISCHARGE AND HIT HER HEAD. THIS LEAD TO A TRIP TO THE EMERGENCY ROOM FOR IMAGING. THE PATIENT THEN PRESENTED AT THE ONE MONTH FOLLOW-UP VISIT WITH A BROKEN FOOT DUE TO ANOTHER FALL. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE EVENT WAS CONSIDERED TO BE ONGOING.

  Patient problems: Fall; Patient Problem/Medical Problem; Weakness

  MAUDE report 6876206 ↗
• InjurySep 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED AN INABILITY TO WALK BUT WAS NOT IMMOBILE, AND WAS DISCHARGED FROM THE HOSPITAL TO A REHABILITATION FACILITY ON (B)(6) 2017. THE PATIENT WAS THEN READMITTED TO THE HOSPITAL ON (B)(6) 2017 FOR SEIZURE ACTIVITY WITH ASSOCIATED WEAKNESS, AND WAS PRESCRIBED ANTICONVULSANTS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FROM (B)(6) 2017. AT DISCHARGE, THE PATIENT HAD WORSENING SYMPTOMS OF WEAKNESS, AND SPEECH/APHASIA. THE EVENT RESOLUTION WAS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Neurological Deficit/Dysfunction; Seizures; Weakness

  MAUDE report 6866392 ↗
• InjurySep 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED A PULMONARY EMBOLISM. THE PATIENT NEEDED AN INFERIOR VENA CAVA (IVC) FILTER INSERTED AND ALSO REQUIRED LOVENOX. THE EVENT RESOLUTION WAS NOT DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Pulmonary Embolism

  MAUDE report 6858933 ↗
• InjurySep 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED INCREASED WEAKNESS, WORSENING COGNITIVE ISSUES, AND WORSENING SPEECH APHASIA. THE PATIENT WAS NOT RELEASED FROM THE HOSPITAL UNTIL (B)(6) 2017 AND REQUIRED INPATIENT OCCUPATIONAL AND PHYSICAL THERAPY. THE EVENT WAS CONSIDERED ONGOING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: Cognitive Changes; Neurological Deficit/Dysfunction; Weakness

  MAUDE report 6858927 ↗
• MalfunctionSep 12, 2017Electrical /Electronic Property Problem; Insufficient Heating; Computer Operating System Problem; Device Operational Issue; Electrical /Electronic Property Problem; Insufficient Heating; Computer Operating System Problem; Device Operational Issue

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, WHILE THE SURGEON WAS ABLATING, THERE "SEEMED TO BE" NO HEATING. UPON CHECKING THE LASER BOX, THE SCREEN WAS COMPLETELY BLANK AND HAD NO POWER. THE MONTERIS REPRESENTATIVE RE-POWERED THE LASER BOX USING THE KEY AT THE BOX, WITHOUT SUCCESS. WHEN RETURNING TO THE CONTROL WORKSTATION (CWS), THE SCREEN WAS FROZEN AND THE MONTERIS REPRESENTATIVE HAD TO USE THE TASK MANAGER TO EXIT M*VISION. THE REPRESENTATIVE THEN CONNECTED TO THE EDCC AND TWO ERRORS APPEARED; ONE STATED THE EDCC HAD STOPPED WORKING, WHILE THE OTHER STATED THAT AN ERROR OCCURRED AND THAT TECHNICAL SUPPORT HAD TO BE CONTACTED. THE EDCC WAS THEN RESTARTED AND THE LASER BOX WAS TURNED ON. THE PHYSICIAN CONTINUED WITH THE ABLATION BUT WITH MINIMAL HEATING. THE CASE WAS THEN ABORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

  Patient problems: No Code Available

  MAUDE report 6858913 ↗