Visualase 9735542 (UDI 00643169792890)Recalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00643169792890), received between Mar 2, 2017 and Feb 27, 2026 — classified as 24 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (18 reports).

1 FDA recall record name this device's identifier.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jun 1, 2018Terminated

   Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue.

   Z-3251-2018 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BRAIN BLEED, UNRELATED TO MEDTRONIC EQUIPMENT. A THIRD PARTY ROBOTIC SURGICAL ASSISTANCE ROBOT WAS USED FOR NAVIGATION. THE BLEED WAS NOT IN THE AREA OF ABLATION. THE CATHETERS PERFORMED AS EXPECTED. ABLATION WAS SUCCESSFULLY PERFORMED AND WERE INSPECTED AFTER THE PROCEDURE. BOTH CATHETERS USED WERE INTACT BEFORE AND AFTER THE PROCEDURE. PER THE SURGEON, NO OTHER SURGICAL INTERVENTION WAS NEEDED WHEN THE PATIENT WAS EVALUATED AFTER THE PROCEDURE. THE PATIENT WAS TO BE MONITORED. THERE WAS A DELAY FOR EVALUATION OF THE PATIENT WHICH WAS 20 MINUTES. THE PATIENT WAS STABLE THE FOLLOWING DAY.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 24471138 ↗
• MalfunctionJan 29, 2026No Device Output; Failure to Read Input Signal

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE LOCAL REPRESENTATIVE (LASC) CALLED ON BEHALF OF THE SITE TO REPORT THAT WHILE IN A CASE, THE TIO SCREEN OF THE SYSTEM BEGAN DISPLAYING " POWER BUTTON LOCK" AND THE SURGEONS COULD NO LONGER USE THE SCREEN. BASED ON THE DESCRIPTION, TECHNICAL SERVICES (TS) BELIEVED THAT THIS WAS THE V1 MONITOR TOUCH SCREEN ISSUE THAT OCCURRED WHEN THE POWER BUTTON ON THE MONITOR WAS PRESSED. THE WHOLE SCREEN WAS BLACK WITH THE MESSAGE, NO VIDEO AT ALL. THE LASC TEAM TRIED REBOOTING AND RESEATING ALL CABLES INTO THE MONITOR WITH NO CHANGE. ANOTHER LOCAL REPRESENTATIVE (REP) CALLED TO REPORT THAT SHE MOVED THE DISPLAY PORT (DP) FROM THE LOWER SCREEN TO THE UPPER MONITOR, AND THE VIDEO WAS RESTORED. THE REP CONFIRMED THAT SHE ONLY MOVED THE MONITOR DP CABLE FROM THE LOWER TO THE UPPER MONITOR, BUT NEVER SWAPPED CONNECTIONS ON THE COMPUTER SIDE AS WELL. IT WAS NOTED THAT POTENTIALLY, THIS COULD BE A COMPUTER ISSUE, BUT HAS YET TO BE TESTED. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. PATIENT IMPACT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209274 ↗
• MalfunctionMar 17, 2025Insufficient Heating; Insufficient Heating

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THE LASER GENERATOR TEST FAILED. THE TEST FAILED DUE TO THE LASER OUTPUT BEING TOO LOW. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620439 ↗
• MalfunctionJun 13, 2024Failure to Read Input Signal; Failure to Read Input Signal

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT WHILE SCANNING THE PATIENT WITH 3 FIBERS IN THEIR HEAD, THEY ENCOUNTERED A POP-UP MESSAGE DURING REFORMATTING IN VIEW GO. THEY CLICKED OK AND IT SHUT DOWN VIEW GO. KNOWING THAT LIKELY THIS WOULD DISRUPT THEIR ABILITY TO TRANSFER THE REFORMATS TO THE FILM STRIP ON THE SCANNING SIDE, THEY PROCEEDED JUST IN CASE IT WOULD WORK. IT DID NOT WORK. THEY CLOSED OUT THE PATIENT AND STARTED FRESH FROM THE BEGINNING. THIS RESOLVED THAT ISSUE, THEY ARE UNSURE AS TO WHY THIS ERROR HAPPENED. THERE WAS A DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT'S OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534410 ↗
• MalfunctionMay 24, 2024Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem; Incorrect, Inadequate or Imprecise Result or Readings; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. A MEDTRONIC REPRESENTATIVE (REP) REPORTED THAT DURING SURGERY, "WE PERFORMED ALL SETUP ACCORDING TO SOP AND ABLATED OUR FIRST FIBER JUST LIKE NORMAL. WHEN WE SWITCHED TO THE NEXT FIBER, WE ENCOUNTERED AN ISSUE. THE SCANS WOULD ACQUIRE BOTH PLANES, WE COULD SEE BOTH PLANES IN VDT, BUT THE IN SESSION WOULD NOT PULL BOTH PLANES. IT WOULD PULL ONLY THE SAGITTAL PLANE AND NOT THE CORONAL PLANE. KEEP IN MIND THAT ALL REFORMATTED PLANES FROM ALL THREE FIBERS RENDERED 3 SAG, 2 AXIAL, AND 1 CORONAL. THIS CAUSED US TO CONSIDER IF THE CORONAL WAS THE ISSUE BY CHANCE FOR SOME REASON OR ANOTHER. IN AN ATTEMPT TO FIX THE ISSUE, WE COPIED DOWN THE TMAP FROM THE FIRST SUCCESSFUL FIBER BURN AND MODIFIED THE COPY IMAGE POSITION TO SCAN ACCORDINGLY FOR THE 2ND FIBER LOCATION. WE ASSUMED THAT MAYBE THE TMAP HAD BECOME CORRUPT AND USING ONE THAT HAD JUST WORKED FINE FOR US MAY BE A RESOLUTION. IT WAS NOT. THEN WE DECIDED TO PROCEED AND SEE IF THE 3RD FIBER WOULD SCAN AND PULL IMAGES PROPERLY AND IT DID. WE ELECTED TO COMPLETE FIBER 3 SINCE ALL THINGS WERE WORKING FOR THAT ONE AN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19391253 ↗
• MalfunctionMar 28, 2024Failure to Read Input Signal; Connection Problem; Failure to Read Input Signal; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE SOFTWARE WAS REVERTING. WHILE IN SURGERY THE SYSTEM LOCKED UP AND THEY HAD TO REBOOT THE SYSTEM. AFTER REBOOTING THE SYSTEM THE SOFTWARE REVERTED FROM SOFTWARE VERSION 3.4 TO VERSION 3.3.2 AND THEY LOST THE SYSTEM CONFIGURATION. AS THEY GOT THE SYSTEM BACK UP AND RUNNING THE SYSTEM LOCKED UP AGAIN. AFTER REBOOTING THEY SAW THE SAME REVERTING SOFTWARE ISSUE. THEY WERE EVENTUALLY ABLE TO CONTINUE WITH SURGERY. THERE WAS NO DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE STATING THAT THEY HAD SOME INITIAL ISSUES CONNECTING IN THE MORNING AS WELL. UPON BOOTING UP, THE SYSTEM CONFIGURATION THAT WAS LOADED WAS A MIX BETWEEN TWO CONFIGURATIONS. THE THERMAL THERAPY SYSTEM CONFIGURATION PAGE WAS CORRECT (SCANNER IP AND CONSOLE TYPE) BUT THE IP SETUP WAS PULLING IP INFO (IP ADDRESS AND SUBNET MASK) FROM AN OLD CONFIGURATION. THE SITE SELECTED THE CORRECT SYSTEM CONFIGURATION FOR THE SCANNER THAT THEY WERE GOING TO BE USING TO UPDATE THE IP SETUP INFORMATION AND THIS LOCKED THE SYSTEM UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18991930 ↗
• InjuryAug 21, 2023Mechanical Problem; Failure to Read Input Signal; Connection Problem; Mechanical Problem; Failure to Read Input Signal; Connection Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE SITE HAD PERFORMED TWO ABLATIONS ON THE FIRST FIBER. THAT TEMPERATURE MAP (TMAP) SEQUENCE WAS GETTING TOWARD THE END OF ITS ~20 MINUTE LENGTH, SO THEY STOPPED IT AFTER WATCHING THE TEMP RETURN TO BASELINE. THEY TURNED THE SALINE PUMP OFF WHILE SURGEON WAS IN THE ROOM DOING THE PULLBACK. A FEW MINUTES LATER, ANOTHER TMAP SCAN WAS STARTED AND SALINE PUMP TURNED BACK ON. A COUPLE MINUTES INTO THE SCAN, THE SURGEON TRIED TO DO A TEST DOES AND THE MANUAL LASER CONTROL WINDOW SAID "SOMETHING LIKE 'LASER CONNECTION ERROR.'" THEY CYCLED POWER ON THE LASER GENERATOR AND GOT SAME MESSAGE. THEY ENDED THE SESSION AND STARTED A NEW ONE. THAT TIME, THEY GOT THE "DO NOT CONNECT LASER! LASER PORT BUSY/UNAVAILABLE" MESSAGE IN THE MANUAL LASER CONTROL WINDOW. THEY THOUGHT THE USB CABLE THAT CONNECTED THE LASER TO THE COMPUTER MAY HAVE BECOME DISCONNECTED, SO THE LOCAL REPRESENTATIVE (CC) CHECKED THE BACK OF THE COMPUTER. WHILE CHECKING, THE COMPUTER SHUT OFF. THE CC CONFIRMED THE POWER CORD WAS STILL PLUGGED IN AND WAS IN A RED CONTINUOUS POWER OUTLET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17587707 ↗
• MalfunctionMay 17, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  THE REPORTED CAUSE IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16946040 ↗
• MalfunctionApr 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE PATIENT MOVED SLIGHTLY, DUE TO HOW THEY WERE PINNED IN THE HEAD HOLDER. THE PURPLE LINE DOES NOT CORRESPOND TO THE SAME PLACE ON THE DOT ARTIFACT FROM THE FIBER OR THE BRAINSTEM IN ALL THREE IMAGES. THE COMPETITOR REPRESENTATIVE ALSO REVIEWED THE 3D IMAGES TAKEN FOR THE FIRST TRAJECTORY AND NOTICED A SLIGHT SHIFT IN THEM. THE HEALTH CARE PROFESSIONAL STATED THAT THE WAY THEY PINNED THE PATIENT WAS NOT IDEAL AND THE SMALL MOVEMENT WOULD BE CONSISTENT WITH THE PIN PLACEMENT. ALSO THEY MADE THE FOLLOWING SUGGESTIONS FOR BETTER VISUALIZATION OF THE TMAP IMAGE WHEN USING FLEX COILS AND LOW POWERS AND SHORT LASER ON TIMES THAT ARE TYPICAL WITH "HH AND CP" CASES: DROP THRESHOLD FROM DEFAULT OF 40 IF IT APPEARS PIXELS ARE DROPPING OUT IN THE CENTER OF THE ABLATION ZONE. DROP THE FALSE COLOR FROM DEFAULT OF 42 TO 40 TO VISUALIZE PIXELS MORE QUICKLY ON THE LOWER POWER TEST DOSE (AFTER A CHANGE IN TEMPERATURE OF 3 DEGREES FROM THE BASELINE OF 37, VERSUS 5 WHEN 42 IS USED) AND TO SEE MORE OF THE LOW TEMPERATURE EDGE. FOR THE THERMAL THERAPY TEAM, THIS METHOD OF USING THE MEASURE TOOL TO ASSESS MOVEMENT ONLY WORKS FOR THE COMPETITOR, AS IT HAS THE OPTION TO COPY IMAGE POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16785117 ↗
• MalfunctionMar 1, 2023Component Missing; Component Missing

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE CATHETER TIP WAS MISSING AFTER INSERTING THE CATHETER INTO THE PNT BOLT AND SURGEON FELT RESISTANCE, TOOK THE CATHETER OUT AND USED STYLET TO MAKE SURE THEY WERE THROUGH DURA AND THEN WENT TO REINSERT THE CATHETER WHEN THEY NOTICED THE TIP WAS MISSING. THERE WAS A DELAY OF LESS THAN 1 HOUR AND NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460490 ↗
• InjuryJan 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT TISSUE NEURO ABLATION PROCEDURE. IT WAS REPORTED THAT POST-OPERATIVELY AT THE THREE MONTH POST FOLLOW-UP OPHTHALMOLOGICAL EXAM, THE PATIENT HAD A LEFT SUPERIOR HOMONYMOUS QUADRANTANOPIA. A VISUAL FIELD DEFICIT WAS NOTED. IT WAS REPORTED THAT THE ADVERSE EVENT (AE) WAS RELATED TO THE DEVICE AND THE PROCEDURE. HOWEVER, IT WAS NOT RELATED TO ANESTHESIA OR AN EPILEPTIC DISEASE-STATE. THE SEVERITY OF THE AE WAS MODERATE. THERE WERE NO OTHER ACTIONS TAKEN, AND THE OUTCOME WAS NOT REPORTED. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REQUIRED.

  Patient problems: Visual Impairment

  MAUDE report 16233968 ↗
• MalfunctionDec 19, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN A SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT THE SOFTWARE WAS FORCING INCORRECT TEMPERATURE MAP (TMAP). DURING THE MAGNETIC RESONANCE IMAGING (MRI) PORTION OF THE CASE, THE TMAP IMAGES WOULD FLIP. THE MANUFACTURER REPRESENTATIVE (REP) STATED THAT THEY HAD TAKEN A QUICK ADDITIONAL TMAP SCAN IN BETWEEN RUNNING THE FIRST SCAN AND PULLING A NEW TMAP FROM PROTOCOL. THEY WERE UNABLE TO GET THE SWAPPING TO RESOLVE USING A KNOWN WORKAROUND METHOD REPORTED BY ENGINEERING. THE REP SUSPECTED THIS WAS DUE TO HAVING TAKEN AN ADDITIONAL SCAN. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004964 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT POST OPERATIVELY, THE PATIENT WAS HAVING DIFFICULTY WITH MEMORIAL AND RECALL. THE PATIENT ALSO FELT THAT SHE NEEDED MORE TIME WITH WORD FINDING, WORK SUBSTITUTION AND SPELLING. IT WAS UNKNOWN IF ANY ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Dysphasia; Memory Loss/Impairment

  MAUDE report 15847582 ↗
• MalfunctionNov 18, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. THE PROCEDURE BEING PERFORMED AS A LASER INTERSTITIAL THERMAL THERAPY (LITT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15824238 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT DURING A 3 MONTH NEUROOPHTHALMIC EXAM, THE PATIENT HAD A VISION TEST AND SHOWED LEFT EYE SUPERIOR CENTRAL VISUAL DEFECTS. THE PATIENT DIDN'T COMPLAIN OR SHOW ANY DEFICIT IN THE CLINICAL EXAM BOTH BY PI AND OPTHALMOLOGIST. THE PATIENT WAS SCHEDULED FOR A 6 MONTH FOLLOW UP EXAM. NO INTERVENTION WAS REQUIRED.

  Patient problems: Visual Impairment

  MAUDE report 15759268 ↗
• MalfunctionNov 1, 2022Mechanical Problem; No Device Output; Mechanical Problem; No Device Output

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM. IT WAS REPORTED THAT THE PATIENT WAS UNDER FOR 5.5-6 HOURS BEFORE CASE STARTED. AFTER GETTING INTO THE PROCEDURE, USING IMAGES FROM A GE SCANNER RUNNING SOFTWARE (SW) 29.1, TEMPERATURE MAP (TMAP) WERE SWAPPING. THE SYSTEM WAS USING SW VERSION 3.4. IT WAS ALSO DISCOVERED THAT THERE WAS A PINHOLE LEAK IN THE COOLING CATHETER. ADDITIONAL INFORMATION WAS RECEIVED. THIS OCCURRED DURING A SOFT TISSUE ABLATION. THE SITE RAN THE TMAP AND DID THE 1ST ABLATION, SCAN WAS STOPPED SO THEY COULD GO INTO THE ROOM TO DO A PULL BACK. THEY STARTED THE 2ND TMAP AND IT WAS NOTICED THE IMAGES WERE SWAPPED. THEY STOPPED THE SCAN, COPY AND PASTED THE SCAN AND RAN IT AGAIN, THE SCANS WERE STILL IN THE EXACT SAME (SWAPPED) POSITION. THEY STOPPED THAT SCAN, AND HAD THE MAGNETIC RESONANCE IMAGING (MRI) TECH PULL A NEW TAMP OUT OF THE PROTOCOL, COPY THE IMAGE POSITIONS FROM THE PREVIOUS SCANS, BUT HAD HIM RENTER THE CVS. THE TMAP IMAGES RETURNED TO THE ¿ORIGINAL¿ POSITION (HOW THEY PRESCRIBED THEM FOR THE 1ST. SCAN). THEY DID AN ABLATION, STOPPED THE TMAP SCAN. THEY JUST COPIED AND PASTED THE LAST TMAP WE RAN (THE ONE WHERE WE ENTERED THE CVS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15707602 ↗
• MalfunctionOct 31, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN A PROCEDURE. IT WAS REPORTED THAT THE SOFTWARE WAS FORCING INCORRECT TEMPERATURE MAP (TMAP). THIS OCCURRED DURING THE MAGNETIC RESONANCE IMAGING (MRI) PORTION OF THE CASE, THE TMAP IMAGES WOULD CONTINUOUSLY SWAP. THE SCANNER SOFTWARE VERSION AND SYSTEM SOFTWARE WAS RECENTLY UPGRADED DUE TO SAME ISSUE. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO PATIENT OUTCOME. THE TYPE OF PROCEDURE WAS A SOFT TISSUE ABLATION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698799 ↗
• MalfunctionOct 25, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN A PROCEDURE. IT WAS REPORTED THAT THE SOFTWARE WAS FORCING INCORRECT TEMPERATURE MAP (TMAP). DURING THE MAGNETIC RESONANCE IMAGING (MRI) PORTION OF THE CASE, THE TMAP IMAGES WOULD CONTINUOUSLY SWAP. THE MANUFACTURER REPRESENTATIVE (REP) STATED THE MRI TECH HAD TO COPY/PASTED THE SAME TMAP, BUT THE SOFTWARE WAS FORCED ON A DIFFERENT IMAGE. THE REP MENTIONED THE TEAM WAS USING A NON-MEDTRONIC SCANNER. IT WAS ALSO STATED THAT THIS WAS THE 2ND TIME THIS HAPPENED AT THE SITE. THE FIRST TIME THE TMAPS DIDN¿T SWAP EVERY NEW SESSION BUT THEY DID SWAP AT LEAST 3 OR 4 TIMES. ON OCTOBER 3RD, THE TMAP IMAGES SWAPPED EVERY TIME THEY STARTED A NEW LIVE SESSION. THE MRI TECH COPY AND PASTED THE TMAP, WHICH MEANS THEY DID NOT SWAP THE IMAGES. THIS WAS THE SAME WAY THEY HAVE BEEN DOING IT FOR YEARS. THERE WAS LESS THAN AN HOUR DELAY TO THE CASE. NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667669 ↗
• MalfunctionOct 25, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT A SESSION WAS RAN AND THEN THE SITE RAN OUT OF TIME ON THE MAGNETIC RESONANCE IMAGING (MRI) TEMPERATURE MAP (TMAP) SCAN. THEY CLOSED THAT SESSION AND OPENED A NEW SESSION MRI AND COPIED AND RAN ANOTHER TMAP. WHEN THE IMAGES CAME TO THE SYSTEM THE BACKGROUND SLICES HAD FLIPPED FROM THE FIRST SESSION. THE MEDTRONIC REPRESENTATIVE HAD THE MRI TECHNICIAN STOP THAT TMAP AND COPY ANOTHER ONE. THEY RAN THAT AND THE BACKGROUND IMAGES HAD FLIPPED BACK TO THE ORIGINAL STARTING POSITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15666097 ↗
• MalfunctionOct 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED INTRAOPERATIVELY DURING A PROCEDURE. IT WAS REPORTED THAT DURING THE MAGNETIC RESONANCE IMAGING (MRI) PORTION OF THE CASE, THE TEMPERATURE MAP (TMAP) IMAGES WOULD FLIP. THE SCANNER WAS ON SOFTWARE VERSION 29.1 AND THE THERMAL THERAPY SYSTEM WAS RUNNING ON VERSION 3.4. THERE WAS A SURGICAL DELAY OF LESS THAN ONE HOUR. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639669 ↗
• MalfunctionSep 6, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THERE WAS A SOFTWARE ERROR DURING THE T MAP SESSION. THE T-MAPS CAME OVER AND THEY WERE SWAPPED. THEY WERE SWAPPED FOR THE SECOND T-MAP SESSION. IT HAPPENED 3-4 TIMES. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. NO REPORTED IMPACT TO THE PATIENT. THE MANUFACTURER REPRESENTATIVE BELIEVES THEY SET THE TMAP SEQUENCE UP TO RUN THE SAGITTAL IMAGE FIRST AND THE CORONAL IMAGE SECOND. THE FIRST ABLATION WENT FINE, THEY STOPPED THE SCAN AND DISCONNECTED FROM THE SCANNER. THEY COPIED AND PASTED THE SAME SEQUENCE AND RERAN IT FOR THE NEXT ABLATION. THE IMAGES WERE SWAPPED (COR #1 AND SAG #2), THE REP HAD TO USE THE SWAPPED IMAGES AND SWAPPED TARGET BUTTONS. THE IMAGES KEPT SWAPPING WITH EACH NEW SEQUENCE (NOT EVERY TIME, BUT ALMOST EVERY TIME). WHEN POST PROCESSING THE MOVIES THERE WAS ONE LOG FILE THAT WAS SWAPPING THE DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362766 ↗
• MalfunctionApr 11, 2022Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A PROCEDURE. IT WAS REPORTED THAT FOUR SETS OF TUBING EXPERIENCED A PINHOLE LEAK DURING THE PROCEDURE. IT WAS REPORTED THAT THE LEAK REQUIRED STOPPING THE MAGNETIC RESONANCE IMAGING (MRI) ON EACH OCCURRENCES, ACQUIRING A NEW TABLE AND CONTINUING. ADDITIONALLY IT WAS NOTED THAT 5 LASERS WERE CHAINED TOGETHER. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REPORTED ISSUE OCCURRED DURING A SOFT TISSUE NEURO ABLATION. THERE WAS A 10-15 MIN DELAY GIVEN THAT THEY HAD TO PHYSICALLY MOVE THE PATIENT ONTO ANOTHER MRI TABLE. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14078951 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM DURING A SOFT TISSUE ABLATION. IT WAS REPORTED THAT THE PATIENT WAS FOUND TO HAVE A LARGE HEMORRHAGE AND REQUIRED A SECONDARY PROCEDURE OF EMERGENCY CRANIOTOMY THAT SAME NIGHT. THE PROCEDURE WAS NOT DELAYED.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 13930443 ↗
• MalfunctionFeb 22, 2022Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings; Mechanical Problem; Incorrect, Inadequate or Imprecise Result or Readings

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION OF THE PREFRONTAL CORTEX. IT WAS REPORTED THAT ONE OF TWO CATHETERS USED IN THE PROCEDURE HAD A CHARRED TIP. IT WAS NOTED THAT LASER SETTINGS WERE AT 10W WITH A POWER SETTING OF 30% WHILE ABLATIONS WERE SET FOR A BURN TIME OF 30-60 SECONDS. FOLLOWING AN INITIAL ABLATION, IT WAS NOTED THAT THE TEMPERATURE MAP (TMAP) APPEARED TO BE IRREGULAR. THE FACILITY THEN SWITCHED TO USING ONLY THE SECOND LASER FIBER WITH THE SAME CATHETER WHICH RESTORED THE IRREGULAR TMAP. ONCE REMOVED; THE FIRST LASER FIBER WAS FOUND TO BE CHARRED, THE SECOND LASER FIBER WAS NOT AND THE LASER CATHETER WAS INTACT. HOWEVER, THERE WAS RESIDUE NOTED ON THE DISTAL END OFTHE CATHETER. THERE WAS NO REPORTED DELAY TO THE PROCEDURE DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13578294 ↗
• MalfunctionDec 30, 2021Mechanical Problem; Unexpected Therapeutic Results; Mechanical Problem; Unexpected Therapeutic Results

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION. IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS NOTED TO HAVE BEEN CHARRED AND BLUNTED UPON REMOVAL FROM THE ANATOMY. IT WAS NOTED THAT DURING AN INITIAL ABLATION, THE THERMAL THERAPY SYSTEM APPEARED TO HAVE ABOUT FIFTY SECONDS OF RAPID HEATING INTO THE TREATMENT WHICH RESULTED IN THE LASER POWERING OFF. IT WAS NOTED THAT THE FIRST ABLATION WAS IN THE SAME REGION WHERE THE BIOPSY WAS PERFORMED AND THE RAPID HEATING DID NOT RECUR DURING TWO OTHER ABLATIONS. POST-OPERATIVE SCANS WERE REPORTED BY THE SURGEON TO BE SUFFICIENT AND THE SURGEON TESTED THE CATHETER AND FOUND SALINE FLOWED THROUGH THE OUTFLOW TUBING BUT NOT THE CHARRED END OF THE CATHETER. IMAGING AND SALINE RETURN INTRA-OPERATIVE WAS REPORTED TO HAVE SHOWN NO SIGNS OF LEAKAGE IN THE TUBING. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117849 ↗