Visualase 9735560 (UDI 00763000218188)Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00763000218188), received between Jul 15, 2019 and Jun 30, 2023 — classified as 4 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (31 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 44 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED INTRAOPERATIVELY. IT WAS REPORTED THAT THERE WAS A SUBDURAL HAEMATOMA NOTICED ON MRI SCANS AT CORTICAL ENTRY AFTER THE PATIENT WAS TAKEN TO THE RADIOLOGY DEPARTMENT IMMEDIATELY POST-INSERTION OF THE SKULL POST AND LASER FIBRE. THE PATIENT RETURNED TO THE OPERATING THEATRE WITHOUT PERFORMING LASER ABLATION, THE SKULL POST AND LASER FIBRE WERE REMOVED, AND A CRANIOTOMY AND DRAINAGE OF SUBDURAL HEMATOMA PERFORMED. ONE OF THE ATTENDING SURGEONS SPOKE TO THE MEDTRONIC REPRESENTATIVE (REP) ABOUT THE SKULL POST. THE DOCTOR WAS QUESTIONING HOW SHARP THE THREAD WAS. HE SAID THAT DURING THE PROCEDURE, THE POST HAD FELT "LOOSE" WHEN THEY HAD REMOVED IT. HE ALSO WAS QUESTIONING THE SHARPNESS OF THE END OF THE DRILL BIT. THE PATIENT REMAINED HOSPITALIZED WITH APPROXIMATELY 50% VISUAL IMPAIRMENT FROM THE SUBDURAL HEMATOMA ACQUIRED DURING THE PROCEDURE. THERE WAS A DELAY OF UNKNOWN TIME.

  Patient problems: Hematoma; Unspecified Tissue Injury; Visual Impairment

  MAUDE report 17236785 ↗
• MalfunctionFeb 18, 2022Insufficient Heating; Insufficient Heating

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT THERE WAS TISSUE OR BLOOD CLOTTING OBSERVED ON THE TIP OF TWO LASER FIBERS. IT WAS NOTED THAT THE ISSUE OCCURRED WHEN UTILIZING TWO CATHETERS SIMULTANEOUSLY. ADDITIONALLY, IT WAS REPORTED THAT IT WAS SUSPECTED THE ISSUE WAS NOT CAUSED BY A PRODUCT MALFUNCTION, HOWEVER THE REPORTED ISSUE RESULTED IN AN INCOMPLETE ABLATION AS DESIRED RESULTS COULD NOT BE ACHIEVED. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT IT WAS CONFIRMED THAT THE PATIENT WILL UNDERGO RADIOTHERAPY. THE PROCEDURE WILL NOT BE DELAYED BY THE REPORTED PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560878 ↗
• MalfunctionDec 1, 2021Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A SOFT TISSUE ABLATION NEURO PROCEDURE. IT WAS REPORTED THAT THE 10 MILLIMETERS CORE FIBER TIP STOPPED WORKING MID PROCEDURE. THE SITE DID TWO PULL BACKS WITH THE FIBER AND EVERYTHING WORKED FINE. THEN AFTER A THIRD PULL BACK, THE SITE COULD NO LONGER SEE THE TEST DOES OF 20% ON THE TMAP. THE SITE RESTARTED THE TMAP AND TRIED AGAIN, BUT STILL IT DIDN'T SHOW UP. AFTER RESTARTING TMAP AND CHECKING THE LASER FOR BREAKS, THE SITE OPENED A NEW LASER AND REPLACED THE OLD WHILE THE PATIENT WAS STILL IN THE MRI SCANNER. CHANGING THE LASER FIBER WORKED AND THE SITE WAS ABLE TO FINISH THE PROCEDURE AS PLANNED. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908726 ↗
• MalfunctionOct 29, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE IRRIGATION TUBING HAD A LEAK NEAR THE PUMP. THIS CAUSED A DELAY OF LESS THAN ONE HOUR AND NO SYSTEM DAMAGE. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720312 ↗
• MalfunctionSep 13, 2021Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN OUT OF BOX FAILURE WITH THE DISPOSABLE KIT. IT WAS REPORTED THAT THERE WAS A TUBING PROBLEM; THE SALINE DID NOT FLOW OR DRIP FROM TUBE. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12461069 ↗
• MalfunctionSep 13, 2021Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED OUTSIDE OF A PROCEDURE. IT WAS REPORTED THAT THERE WAS AN OUT OF BOX FAILURE WITH THE DISPOSABLE KIT. IT WAS REPORTED THAT THERE WAS NO FLOW IN THE HYDRAULIC PUMP SEGMENT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12461007 ↗
• MalfunctionSep 2, 2021Infusion or Flow Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, IT WAS NOTED THAT SALINE WAS CONSISTENTLY DRIPPING FROM THE EXIT SIDE OF THE PUMP TUBING INTERFACE WHERE THE TUBING WAS ATTACHED TO THE ¿BLADDER¿ WHICH SAT CLAMPED IN THE PUMP ASSEMBLY. THREE COOLING CATHETERS WERE DAISY CHAINED SO SALINE WAS BEING CIRCULATED THROUGH ALL THREE. THE SURGEON HAD VERY OPTIMAL RETURN ON THE SALINE RETURN BAG AND NO SIGNS OF AIR BEING DRAWN INTO THE TUBING. THE SURGEON OPTED TO PROCEED WITH THE FIRST ABLATION AS SO AND WHILE CHANGING OVER TO ABLATE THE SECOND OF THREE CATHETERS, THEY OPTED TO SWITCH OUT THE PUMP SIDE TUBING BUT LEFT THE ORIGINAL EXTENSION TUBING IN PLACE. THIS RESOLVED THE LEAK AND THE CASE PROCEEDED. THERE WAS NO DELAY AS THE TUBING WAS SWAPPED WHILE THE MAGNETIC RESONANCE IMAGING (MRI) WAS PREPPING THE SCANS FOR THE NEXT LASER. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12413511 ↗
• MalfunctionAug 11, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, NEAR THE END OF THE PROCEDURE, THE TUBING STARTED TO LEAK. IT DID NOT IMPACT THE CASE. THIS OCCURRED WHEN THEY ADJUSTED THE PUMP SETTINGS BY INCREASING TO THE HIGHEST SETTING. THE SITE DID NOT NEED TO OPEN ANOTHER KIT. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. THERE WAS NO REPORTED SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12306439 ↗
• MalfunctionJul 28, 2021Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN A ELECTRODE AND PROBE PLACEMENT PROCEDURE. IT WAS REPORTED THAT  THERE WAS A WATER LEAK IN THE CATHETER INSERTED IN THE PATIENT. THE PATIENT WAS FINE AND THEY DID NOT SUFFER ANY DAMAGE. THE SITE HAD WATER RETURN ALL THE TIME DURING THE PROCEDURE. THE PROBABLE CAUSE OF THE REPORTED ISSUE WAS THAT THE HEALTH CARE PROFESSIONAL DID NOT CLOSE THE CATHETER CHANNEL PROPERLY WHEN THEY DID A PULL BACK OF THE FIBER, SO PART OF THE WATER CAME OUT AND DIDN'T RETURN TO THE DRAINAGE BAG. THE MANUFACTURER REPRESENTATIVE NOTICED THAT THE FLOW GOING OUT OF  THE WATER BAG WAS PRETTY HIGH, AND IT WASN'T THE SAME FLOW THAT CAME INTO THE DRAINAGE BAG, SO THE REP TOLD THE HCP TO STOP THE LASER AND GO INSIDE TO CHECK IF THERE WAS ANY LEAK. THEY NOTICED LIQUID WAS COMING OUT THROUGH THE CATHETER DUE TO THE CATHETER NOT BEING PROPERLY CLOSED AFTER THE PULL BACK. THE HCP WAS ASKED TO CLOSE THE CATHETER TIGHTER AND IT WAS CHECKED THAT NO MORE LIQUID CAME OUT. THERE WAS NO REPORTED DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239295 ↗
• MalfunctionJul 27, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THERE WAS A BROKEN COOLING CATHETER; IT HAD A HOLE IN IT. IT WAS UNKNOWN IF IT HAD THE HOLE IN IT FROM WHEN THE SITE OPENED THE KIT OR IF IT OCCURRED DURING THE PROCEDURE. THE SITE WAS ONLY USING ONE FIBER. IT WAS NOTICED WHEN THEY WERE RUNNING THE SALINE BEFORE STARTING THE ABLATION. THE RETURN TOOK A LOT LONGER THAN NORMAL, SO THE SITE CHECKED IT AND FOUND THE PINHOLE LEAK. THE SITE SWITCHED THE CATHETER OUT AND CONTINUED. THERE WAS A DELAY OF ABOUT 30-40 MINUTES. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231401 ↗
• MalfunctionJul 23, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, AFTER THE COOLING LASER APPLICATOR SYSTEM WAS REMOVED AT THE END OF ABLATION, THE SURGEON NOTICED SOME CHARRING AT THE TIP AND PIN-PRICK LEAK WITH MINUTE LEAKAGE. THE COOLING LASER APPLICATOR SYSTEM WAS REPLACED TO CONTINUE WITH THE SECOND TRAJECTORY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216995 ↗
• MalfunctionJul 23, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, AFTER THE SECOND TRAJECTORY AND COMPLETION OF ABLATION, A PIN-PRICK LEAK WAS DETECTED AT THE END OF THE CATHETER. WHEN PRESSURE WAS APPLIED TO THE SALINE, A SMALL AMOUNT OF FLUID LEAK WAS REVEALED. THERE WAS NO IMPACT TO THE PATIENT AND NO ACTION AS THE ABLATION HAD BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216955 ↗
• InjuryMay 27, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE COOL CATHETER LEAKED. IT WAS REPORTED THAT A TOTAL OF THREE WERE CHAINED TOGETHER AND THE MIDDLE CATHETER LEAKED INTO THE PATIENT'S BRAIN. THIS WAS NOTICED AT THE END WHEN THE SITE DID POST-OPERATIVE IMAGING AND NOTICED THAT THERE WAS FLUID IN THE BRAIN. WHEN THE SITE WENT BACK TO TAKE THE BOLTS OUT, THEY LOOKED AT THE TUBING AND FOUND WHERE IT WAS LEAKING FROM. THE PROCEDURE HAD BEEN COMPLETED WITHOUT ANY SURGICAL DELAY. THE PATIENT WOKE UP WITHOUT ISSUE BUT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) JUST IN CASE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11893068 ↗
• MalfunctionMay 11, 2021Material Fragmentation; Mechanical Problem; Material Fragmentation; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN A SOFT TISSUE ABLATION (NEURO). IT WAS REPORTED THAT THERE WERE TWO ISSUES THAT WERE DISCOVERED WITH THE KIT. THE FIRST ISSUE WAS THAT THE PROTECTIVE TUBE HAD A WAVY FORM AND MARKINGS IN THE BENDS. THE SECOND ISSUE WAS THE THAT THE HEALTH CARE PROFESSIONAL DISCOVERED A MARK AT 60 MM FROM THE DIFFUSION TIP. THE REPORTED ISSUE WAS FOUND DURING THE VERIFICATION PROCESS. TROUBLESHOOTING WAS PERFORMED AND THE CATHETER WAS INSPECTED AND NO DAMAGE WAS FOUND. LIGHT WAS APPLIED TO THE FIBER AND THERE WAS NO APPARENT DIFFUSION AT THE 60 MM MARK. AS THE MARKING WAS UNKNOWN IT WAS DECIDED TO GET A NEW KIT TO BE ON THE SAFE SIDE. THIS ONE ALSO HAD THIS MARKING AND HAD A DIFFERENT LOT NUMBER SO IT WAS DECIDED TO PROCEED WITH THE SECOND FIBER. THERE WAS LESS THAN AN HOUR DELAY IN THE CASE. NO IMPACT ON PATIENT OUTCOME. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE REPORTED CAUSE OF THE EVENT IS UNKNOWN. THEY RECEIVED CONFIRMATION FROM SENIOR LASER ABLATION SURGICAL CONSULTANT THAT THE MARKING AT 60MM WAS PART OF PRODUCTION. SPECIFICALLY THE MARK IS SECOND FIBER PROTECTION LAYER THAT ENDS. INSPECTION DIDN'T SHOW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806035 ↗
• MalfunctionMay 11, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT DURING THE FIRST ABLATION ON FIBER ONE, RAPID HEATING/STEAM WAS OBSERVED. WHEN THE FIBER WAS WITHDRAWN, THE END OF THE CATHETER APPEARED TO BE BURNT. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME OR DELAY. NOTHING ABNORMAL WAS OBSERVED ON THE POST ABLATION IMAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11805509 ↗
• MalfunctionApr 13, 2021Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN A SOFT TISSUE ABLATION (NEURO) PROCEDURE. IT WAS REPORTED THAT THE SHORT SECTION OF TUBING HAD A LEAK NEAR THE MALE CONNECTOR. NOT A PINHOLE, MORE LIKE A SLOW DRIP SIMILAR TO IF THE CONNECTION WASN¿T TIGHT, BUT BEHIND THE CONNECTOR INSTEAD OF BETWEEN THEM. THERE WAS A REPORTED DELAY OF UNDER FIVE MINUTES WHILE THE TUBING SET WAS REPLACED. THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11656887 ↗
• MalfunctionMar 24, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY,  THERE WAS AN OUT OF BOX FAILURE OF THE TUBING IN THE  COOLING LASER APPLICATOR SYSTEM KIT. THERE WAS A LEAK IN THE TUBING RIGHT WHERE THE TUBING MEETS THE LUER ADAPTER. DIFFERENT TUBING WAS USED TO COMPLETE THE PROCEDURE THIS CAUSED A FIVE MINUTE DELAY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11561176 ↗
• MalfunctionMar 12, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CASE WAS COMPLETED USING A NEW FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11473212 ↗
• MalfunctionFeb 24, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION. IT WAS REPORTED THAT THE SALINE TUBING LEAKED AFTER BEING REMOVED FROM THE PACKING UPON PRIMING. TUBING WAS SUBSEQUENTLY REPLACED TO CONTINUE WITH THE PROCEDURE. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF TWO MINUTES DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11372730 ↗
• MalfunctionFeb 23, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT THE CATHETER FOR THE THERAPY SYSTEM HAD VISUAL EVIDENCE OF CHARRING WHEN REMOVING THE CATHETER FROM THE ANATOMY. IT WAS REPORTED A SECOND CATHETER WAS USED WITH RECURRENCE OF THE REPORTED ISSUE. IT WAS NOTED THAT SALINE FLOW THROUGH THE COOLING CATHETER SYSTEM (CCS) WAS SUFFICIENT WITH NO MALFUNCTIONS OF THE PUMP. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11364918 ↗
• MalfunctionFeb 16, 2021Mechanical Problem; Infusion or Flow Problem; Mechanical Problem; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THERE WAS A LEAK IN THE TUBING ON THE PUMP SIDE. THE SITE WAS ABLATING AND NOTICED THAT THEY WERE GETTING LESS SALINE FLOW. IT WAS NOTED THAT THERE WAS A SMALL HOLE IN THE TUBING WHERE THE SALINE WAS LEAKING. THE LEAK CAUSED NO ISSUES WITH THE ABLATION OR THE CASE. THERE WAS NO REPORTED IMPACTED TO PATIENT OUTCOME AND NO REPORTED DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11331532 ↗
• MalfunctionFeb 11, 2021Material Fragmentation; Mechanical Problem; Material Fragmentation; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED FOR A NEURO SOFT TISSUE ABLATION PROCEDURE. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE COOLING CATHETER SYSTEM (CCS) TIP MELTED AND COULD NOT BE PULLED THROUGH. IN AN EFFORT TO REMOVE THE NON-MEDTRONIC BOLT WITHOUT THE T-HANDLE, THE BOLT SHEERED AND TIP OF THE CATHETER CAME OFF AS WELL. THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) PERFORMED FOR A FOREIGN BODY EXAM. THE PATIENT WENT BACK TO THE OPERATING ROOM (OR) FOR REMOVAL. THE TIP OF THE NON-MEDTRONIC BOLT AND CCS WERE SUCCESSFULLY RETRIEVED. THE TOTAL ADDITIONAL TIME TO THE PROCEDURE WAS ONE HOUR. THE PROCEDURE WAS COMPLETED. THERE WAS NO IMPACT TO PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314412 ↗
• MalfunctionFeb 3, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION. IT WAS REPORTED THAT THE TUBING FOR THE THERMAL THERAPY SYSTEM LEAKED. IT WAS NOTED THAT THE TUBING ON THE CONSOLE SIDE CONNECTOR HAD AN EXCESS AMOUNT OF SALINE DRAIN OUT OF THE SYSTEM. REPLACING THE TUBING RESTORED FUNCTIONALITY. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273917 ↗
• MalfunctionJan 28, 2021Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED DURING A SOFT NEURO TISSUE ABLATION. IT WAS REPORTED THAT THE TUBING FOR THE SYSTEM WAS CLOGGED AND LEAKED PRIOR TO THE ABLATION BEGINNING. WHEN CHECKING THE LINES, THE CENTER OF THE LINE'S CONNECTOR WAS CLOGGED AND LEAKING BETWEEN THE TWO ENDS OF THE LINE. REPLACING THE LINE RESTORED FUNCTIONALITY. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11244122 ↗
• MalfunctionJan 22, 2021Material Fragmentation; Material Fragmentation

  MEDTRONIC RECEIVED INFORMATION REGARDING A THERMAL THERAPY SYSTEM BEING USED IN A SOFT TISSUE ABLATION (NEURO). IT WAS REPORTED THAT THE FIBER SNAPPED RIGHT AT THE BOLT. IT HAD A GOOD RETURN AND FLOW THROUGHOUT THE CATHETER PRIOR TO DISCOVERING THAT THE FIBER WAS DAMAGED. THERE WAS LESS THAN AN HOUR DELAY IN THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214048 ↗