NeuroBlate® System 20980Recalls & reported problems

Summary

The FDA's MAUDE database contains 296 adverse event reports that list this exact device (DI 00816589021080), received between Jan 10, 2019 and Sep 23, 2026 — classified as 7 deaths, 119 injuries, 170 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (120 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 296 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Melted

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874209 ↗
• DeathJun 23, 2026Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN LET MONTERIS KNOW THAT THEIR PATIENT FROM THE UCD-135 CASE ON (B)(6) 2026 HAD RECENTLY PASSED. AFTER THE LITT PROCEDURE ON THAT DATE, PATIENT IMAGING SHOWED SIGNIFICANT EDEMA. THE PHYSICIAN PERFORMED A CRANIOTOMY THAT EVENING OR THE NEXT DAY TO RELIEVE PRESSURE FROM THE EDEMA. THE PHYSICIAN COMMENTED THAT THE WHOLE BRAIN SHOWED SIGNIFICANT EDEMA AND NOT JUST ON THE SITE OF LITT SURGERY, AND THE PATIENT PASSED SHORTLY AFTER THE CRANIOTOMY. EXACT DATE OF DEATH IS UNKNOWN TO MONTERIS.

  Patient problems: Cerebral Edema

  MAUDE report 25599734 ↗
• MalfunctionApr 14, 2026Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE LASER FIBER CONNECTION ON THE PANEL BETWEEN THE ELECTRONICS RACK AND THE PORTABLE CONNECTOR MODULE (PCM) WAS THERMALLY FUSED DURING THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874949 ↗
• MalfunctionApr 3, 2026Radiation Leak

  DURING AN ABLATION PROCEDURE ON (B)(6) 2026, IT WAS REPORTED THAT THE LASER PROBE FAILED TO GENERATE ADEQUATE THERMAL ENERGY. THE LASER FIBER FROM THE PEN PANEL TO THE PORTABLE CONNECTOR MODULE (PCM) WAS REPLACED, BUT NO CHANGE IN PERFORMANCE WAS OBSERVED. THE LASER PROBE ITSELF WAS THEN REPLACED, AFTER WHICH HEAT GENERATION WAS SLIGHTLY IMPROVED, THOUGH IT WAS STILL NOTED TO BE SLOWER THAN EXPECTED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. ON (B)(6) 2026, AN ON-SITE INVESTIGATION WAS PERFORMED AND FIELD PERSONNEL IDENTIFIED A DAMAGE WITH BURN MARKS ON THE PRIMARY LASER FIBER THAT RAN FROM THE ELECTRONICS RACK TO THE MRI ROOM, IMPLYING A POTENTIAL UNWANTED LASER EMISSION DURING THE CASE ON (B)(6) 2026. THE DAMAGED FIBER WAS REPLACED DURING THE ON-SITE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776110 ↗
• MalfunctionFeb 27, 2026Melted

  DURING AN ABLATION PROCEDURE ON (B)(6) 2026, A COOLING ERROR WAS REPORTED THAT PREVENTED INITIAL PROBE COOLING. THE ISSUE WAS RESOLVED BY SWAPPING TO A BACKUP PORTABLE CONNECTOR MODULE (PCM) AND SPARE LASER FIBER CABLE, AFTER WHICH THE CASE PROCEEDED WITHOUT FURTHER ISSUE. NO PATIENT INJURY WAS REPORTED. THE ORIGINAL COMPLAINT WAS EVALUATED AND DETERMINED TO BE NON-REPORTABLE. DURING INVESTIGATION OF THE RETURNED PCMS THAT WAS RECEIVED ON 19-FEB-2026, A MELT WAS IDENTIFIED ON THE LASER CONNECTOR OF ONE OF THE BACKUP PCMS THAT WAS USED TO TROUBLESHOOT THE ISSUE. THE CLINICAL SPECIALIST CONFIRMED THAT THIS MELT WAS NOT RELATED TO THE DESCRIBED COOLING ERROR AS THIS PCM'S LASER CONNECTION WAS NOT CONNECTED TO A PROBE OR USED TO FIRE THE NEUROBLATE LASER FOR THIS CASE. THE MELT WAS IDENTIFIED INCIDENTALLY DURING PRODUCT VISUAL INSPECTION AS PART OF THE ORIGINAL COMPLAINT'S INVESTIGATION. THE IDENTIFIED MELT ON THE PCM LASER CONNECTOR RAISES THE POSSIBILITY OF A POTENTIAL UNINTENDED LASER EMISSION AT AN UNDETERMINED TIME PRIOR TO THE RETURN OF THE DEVICE. NO PATIENT HARM RELATED TO THIS FINDING HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24476464 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT AFTER PLACING THE 3.3 SIDEFIRE LASER PROBE AND RUNNING A 3D T1 SCAN, THE PHYSICIAN NOTED THE PRESENCE OF A HEMATOMA. TWO T1 SCANS WERE ACQUIRED APPROXIMATELY 10 MINUTES APART. THE PHYSICIAN COMPARED THE SCANS, OBSERVED GROWTH OF THE HEMATOMA, AND DECIDED TO ABORT THE LITT CASE AND CONVERT TO A CRANIOTOMY TO RELIEVE PRESSURE.

  Patient problems: Hematoma

  MAUDE report 24388815 ↗
• InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A REMASTER SAE FORM, IT WAS REPORTED THAT A PATIENT EXPERIENCED A NEW LESION ALONG THE BIOPSY/LITT TRACK. THE PATIENT UNDERWENT A BIOPSY AND LITT PROCEDURE ON (B)(6) 2025 AND AN MRI ON (B)(6) 2025 SHOWED THIS FINDING. THE TREATING PHYSICIAN DEEMED THE NEW LESION AS POSSIBLY RELATED TO THE NEUROBLATE PROCEDURE AND DEFINITELY RELATED TO THE SURGICAL PROCEDURE. THE PATIENT UNDERWENT A SURGICAL INTERVENTION FOR THE NEW FINDING, DETAILS NOT AVAILABLE AT THIS TIME.

  Patient problems: Solid Tumor

  MAUDE report 23897499 ↗
• MalfunctionDec 26, 2025Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE LASER FIBER CONNECTION AT THE PEN PANEL, WHICH CONNECTS THE LASER FIBER BETWEEN THE PORTABLE CONNECTOR MODULE (PCM) AND THE ELECTRONICS RACK, BECAME THERMALLY FUSED. THE LASER FIBER FROM THE PCM WAS CUT AND A NEW LASER FIBER CONNECTION BETWEEN THE PCM AND ELECTRONICS RACK WAS MADE WITH TWO BACKUP LASER FIBERS THAT WERE ON SITE. THE CASE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23896592 ↗
• MalfunctionNov 10, 2025Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT NO THERMAL HEATING WAS OBSERVED AT THE BEGINNING OF THE ABLATION. THE PROCEDURE WAS PAUSED, AND IT WAS FOUND THAT THE PROBE LASER FIBER HAD BECOME LOOSE, WHICH PREVENTED HEAT FROM TRANSFERRING TO THE PROBE AND CAUSED THERMAL DAMAGE TO THE PROBE LASER FIBER CONNECTOR ON THE PORTABLE CONNECTOR MODULE (PCM). THE LASER FIBER WAS REPLACED WITH A BACKUP AND THE ABLATION PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513998 ↗
• DeathOct 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A REMASTER SAE FORM, IT WAS REPORTED ON POST-LITT PROCEDURE DAY 18, THE PATIENT PRESENTED TO THE ER DUE TO DECREASED APPETITE AND INCREASED GENERALIZED WEAKNESS. THE PATIENT WAS TOO WEAK TO ATTEND HER ONCOLOGY APPOINTMENT, AND IT WAS RECOMMENDED THAT SHE GO IN. UPON ARRIVAL, HER HEART RATE WAS IN THE 130S, AND HER SYSTOLIC BLOOD PRESSURE WAS 69-78. SHE WAS ADMITTED TO THE ICU FOR HEMODYNAMIC MANAGEMENT. CHEST IMAGING INDICATED MODERATE TO LARGE RIGHT PLEURAL EFFUSION WITH MILD TO MODERATE LAYERING LEFT PLEURAL EFFUSION. BLOOD CULTURE CAME BACK POSITIVE FOR HAEMOPHILUS INFLUENZAE, AND URINE CULTURE WAS POSITIVE FOR KLEBSIELLA PNEUMONIAE. ON POST-STUDY PROCEDURE DAY 27, THE PATIENT REMAINED AFEBRILE AND HEMODYNAMICALLY STABLE. WHITE BLOOD CELL COUNT CONTINUED TO INCREASE, AND CHEST IMAGING SHOWED LARGE RIGHT PLEURAL EFFUSION WITH NEAR COMPLETE COMPRESSIVE ATELECTASIS. CT ALSO SHOWED DILATED STOMACH AND DISTAL SMALL BOWEL WITH DECOMPRESSED COLON SUGGESTIVE OF BOWEL OBSTRUCTION. THE PATIENT REMAINED ON ANTIBIOTICS WITHOUT IMPROVEMENT. ON POST-STUDY PROCEDURE DAY 28, PATIENT HAD A COUGH AND DECREASED SATURATIONS OVERNIGHT. WHITE BLOOD CELL COUNT CONTINUED TO INCREASE WITHOU

  Patient problems: Bacteremia; Urinary Tract Infection

  MAUDE report 23436631 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIOR TO THE START OF AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN OBSERVED EVIDENCE OF BLEEDING DURING THE BIOPSY. THE PHYSICIAN ATTEMPTED TO TREAT THE BLEED, AND AN RPD AND 1.6 NB3 PROBE WERE PLACED FOLLOWING THE BIOPSY. SUBSEQUENT MRI SCANS WERE OBTAINED, AND IMAGING CONFIRMED THE PRESENCE OF A BLEED/CLOT. THE PHYSICIAN ELECTED TO ABORT THE LITT PROCEDURE AND PROCEDURE AND PROCEEDED WITH A CRANIOTOMY TO TREAT THE BLEED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 23348145 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A REMASTER SAE FORM, IT WAS REPORTED THAT A PATIENT EXPERIENCED A FEVER OF UNSPECIFIED ORIGIN AND RAPID CHANGE IN MENTAL STATUS ON (B)(6) 2025 AFTER A LITT PROCEDURE ON (B)(6) 2025. THIS EVENT WAS DEEMED AS A SERIOUS REPORTABLE ADVERSE EVENT SINCE THE TREATING PHYSICIAN DETERMINED THE EVENT WAS POSSIBLY RELATED TO THE LITT PROCEDURE AND REQUIRED A NEW HOSPITALIZATION AND SURGICAL INTERVENTION. PATIENT WAS SENT TO AN OUTSIDE HOSPITAL WHERE BLOOD CULTURES WERE TAKEN (LATER GROWING SERRATIA). BRAIN MRI WAS OBTAINED; ABLATION CAVITY OVERALL LOOKS FAIRLY SIMILAR TO POSTOPERATIVE SCAN, THOUGH THERE ARE SMALL AMOUNTS OF DIFFUSION RESTRICTION OVERLYING THE FRONTAL LOBE. ON (B)(6) 2025, IT WAS OBSERVED THAT OVERALL, THE PATIENT'S MENTAL STATUS IMPROVED SINCE DIAGNOSIS WHILE ON ANTIBIOTICS; HOWEVER, MENTAL STATUS CONTINUES TO WAX AND WEAN. REPEAT BRAIN MRI WAS OBTAINED DEMONSTRATING CONCERN FOR PROGRESSIVE INTRACRANIAL INFECTION. THE PATIENT UNDERWENT A SURGICAL WASHOUT WITH CULTURES AND WAS PROVIDED MEDICATION INCLUDING STEROIDS.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 22977415 ↗
• MalfunctionJul 3, 2025Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT AT THE START OF THE ABLATION, THERE WAS NO HEATING OBSERVED ON THE SCREEN. INSIDE THE MRI ROOM, IT WAS NOTICED THAT THE PORTABLE CONNECTOR MODULE (PCM) CONNECTION TO THE LASER FIBER WAS THERMALLY FUSED. REPLACED THE PCM WITH A BACK UP PCM AND THE ABLATION PROCEDURE CONTINUED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398798 ↗
• MalfunctionJun 27, 2025Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT AFTER STARTING THE ABLATION AND PERFORMING MULTIPLE PULLBACKS, HEAT STOPPED REGISTERING ON THE SOFTWARE. LASER CONNECTIONS THROUGHOUT THE SYSTEM WAS INSPECTED, AND IT WAS FOUND THAT THE PORTABLE CONNECTOR MODULE (PCM) TO PROBE LASER CONNECTION WAS THERMALLY FUSED. THE LASER FIBER WAS REPLACED AND THE ABLATION PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE ARE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22346904 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT FOLLOWING THE INITIAL 3-D VALUE METRIC PROBE VOID SCAN, A POSSIBLE BLEED NEAR THE SURFACE OF THE SKULL WAS NOTED ON THE LEFT SIDE. THE SURGEON PROCEEDED WITH THE ABLATION. FOLLOWING THE ABLATION, THE SURGEON TOOK A FLAIR SCAN AND A BLEED WAS CONFIRMED AND HAD PROGRESSED. THE SURGEON DECIDED TO FOLLOW LASER PROBE REMOVAL WITH AN OPEN CRANIOTOMY.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22319658 ↗
• MalfunctionMay 20, 2025Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT TOWARDS THE END OF THE LAST ABLATION, THE USER NOTICED THAT HEAT WAS NOT OBSERVED ON THE SOFTWARE WHILE FIRING THE LASER. THE CLINICAL SPECIALIST WENT TO INVESTIGATE INSIDE THE MR ROOM AND NOTICED THAT THE PORTABLE CONNECTOR MODULE (PCM) TO NB3 PROBE CONNECTION WAS THERMALLY FUSED. THE PHYSICIAN WAS ALREADY SATISFIED WITH THE EXTENT OF THE ABLATION AT THAT POINT SO THE ABLATION WAS CONCLUDED. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053681 ↗
• InjuryMay 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO A REMASTER SAE FORM, IT WAS REPORTED THAT A PATIENT EXPERIENCED HEMIANESTHESIA POST-OPERATIVELY FOLLOWING A LITT PROCEDURE, WHICH REMAINED UNRESOLVED THROUGH THE 3-MONTH FOLLOW-UP VISIT. THE EVENT IS DESCRIBED AS "DENSE LEFT HEMIBODY SENSORY DEFICIT (DISTAL FOOT AND LEFT FACE ABLE TO FEEL PAIN)". THE PATIENT WAS PROVIDED WITH OCCUPATIONAL AND PHYSICAL THERAPY.

  Patient problems: Numbness; Thrombosis/Thrombus

  MAUDE report 22040117 ↗
• MalfunctionMay 16, 2025Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT TOWARDS THE END OF THE ABLATION, IT WAS OBSERVED THAT THE TEMPERATURE STOPPED RISING WHILE FIRING THE LASER. IT WAS DISCOVERED THAT THE E2K-TO-E2K CONNECTION WAS THERMALLY FUSED AT THE PENETRATION PANEL THAT CONNECTS THE LASER FIBER FROM THE PORTABLE CONNECTOR MODULE (PCM) TO THE RACK. AT THIS POINT THE ABLATION PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE ARE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036904 ↗
• MalfunctionApr 25, 2025Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT FOLLOWING TWO SUCCESSFUL ABLATIONS AND PULLBACKS, HEAT ACCUMULATION ON THE NOISE MASK WAS NOT OBSERVED. THE SURGEON REMOVED THEIR FOOT FROM THE FOOT PEDAL AND THE PROBE CONNECTION TO THE PORTABLE CONNECTOR MODULE (PCM) WAS CHECKED. THERMAL FUSION WAS NOTED ON THE E2K-TO-E2K CONNECTOR BETWEEN THE PROBE LASER FIBER AND THE PCM. A BACKUP PCM AND NEW PROBE WAS USED TO RESUME THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21912944 ↗
• MalfunctionApr 1, 2025Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT A DROP IN LASER HEATING WAS OBSERVED AFTER ~75% OF THE ABLATION WAS COMPLETED. THE USER ENTERED THE MRI ROOM TO INVESTIGATE AND FOUND THAT THE PROBE LASER FIBER WAS THERMALLY FUSED TO THE CONNECTION AT THE PORTABLE CONNECTOR MODULE (PCM). THE PROBE LASER FIBER AND PCM WAS REPLACED AND THE ABLATION PROCEDURE WAS ABLE TO PROCEED WITH NO FURTHER ISSUES. THERE ARE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21743130 ↗
• MalfunctionFeb 13, 2025Unexpected Shutdown; Unexpected Shutdown

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE MONITOR SHUT OFF. THE EMERGENCY STOP BUTTON WAS ENGAGED TWICE, AUDIBLE BEEPING CONTINUED, THEREFORE THE LASER FIBER WAS DISCONNECTED FROM THE PORTABLE CONNECTOR MODULE (PCM) TO ENSURE THAT THE ABLATION HAS STOPPED. THE SURGEON WAS ABLE TO RESUME THE CASE WHERE IT LEFT OFF AFTER THE MONITOR TURNED BACK ON. THERE WERE NO FURTHER ISSUES REPORTED AND NO PATIENT COMPLICATIONS IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21374762 ↗
• MalfunctionDec 30, 2024Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT HEATING STOPPED DURING THE FINAL ABLATION AT THE THIRD POSITION. UPON ENTERING THE ROOM TO INSPECT THE LASER, IT WAS DISCOVERED THAT THE PROBE LASER FIBER HAD THERMALLY FUSED TO THE PORTABLE CONNECTOR MODULE (PCM). THE LASER PROBE AND THE PCM WAS REPLACED, AND THE ABLATION WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21045076 ↗
• MalfunctionDec 26, 2024Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT AFTER 4 MINUTES OF ABLATING, THE HIGHEST TEMPERATURE READING STARTED TO STEADILY DECREASE. THE LASER WAS STOPPED AND THE MATING ADAPTER ON THE PORTABLE CONNECTOR MODULE (PCM) WAS CHECKED. IT WAS FOUND THAT THE PROBE LASER FIBER HAD THERMALLY FUSED AT THE PCM MATING ADAPTER. THE ABLATION WAS THEN CONCLUDED AS THE SURGEON CONFIRMED THAT THE ABLATION HAD BEEN COMPLETED. THERE ARE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21022764 ↗
• MalfunctionDec 12, 2024Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE PROBE LASER FIBER WAS THERMALLY FUSED TO THE CONNECTION POINT ON THE PORTABLE CONNECTOR MODULE (PCM) DURING INITIAL ATTEMPT TO ABLATE LESION. THE LASER FIBER FROM THE PCM AND THE PROBE WAS REPLACED, AND THE ABLATION PROCEDURE RESUMED WITH NO OTHER REPORTED ISSUES. THERE ARE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20919035 ↗
• MalfunctionNov 11, 2024Melted; Melted

  DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE LASER PROBE CONNECTOR THERMALLY FUSED AT THE PORTABLE CONNECTOR MODULE (PCM) MATING ADAPTER AT THE START OF THE THIRD TRAJECTORY. A BACKUP LASER FIBER CABLE AND A NEW LASER PROBE WAS USED TO COMPLETE THE ABLATION PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20654133 ↗