Myosure Reach Tissue Removal Device 10-401FCRecalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 15420045504530), received between Apr 11, 2018 and Sep 24, 2026 — classified as 4 deaths, 58 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 99 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Component Missing

  It was reported that during a MyoSure procedure on (b)(6) 2026, the cutting window/blade was found to be missing from the device during the procedure. When the device was activated, it made an unusual sound and displayed a message indicating that no device was detected. Upon assessment of the device, it was noted that the blade was missing. No missing parts were found in the patient or within the device packaging. A second device was used to successfully complete the procedure. Due diligence has been completed, and no additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884083 ↗
• MalfunctionSep 22, 2026Material Disintegration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860509 ↗
• MalfunctionSep 21, 2026Material Disintegration

  It was reported during a MyoSure procedure on (b)(6) 2026, that during the end of the procedure the physician notes metal shavings in the uterine cavity. The physician ended the procedure and the procedure was completed with the same device. Due diligence is complete and there is no additional information available.

  Patient problems: Foreign Body In Patient

  MAUDE report 50841484 ↗
• MalfunctionSep 21, 2026Defective Device; Mechanics Altered

  PATIENT BROUGHT TO THE OR FOR HYSTEROSCOPY, ABLATION AND POLYPECTOMY. THE INSTRUMENT WAS TESTED PRIOR TO INTRODUCING THE INSTRUMENT TO PATIENT. IT WAS NOTED THAT THE BIT WAS NOT TURNING. A NEW MYOSURE REACH WAS OBTAINED. DEFECTIVE MYOSURE WAS TAKEN OFF THE SURGICAL FILLED, SAVED AND GIVEN TO NSM "[nurse surgical manager]".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838737 ↗
• MalfunctionAug 6, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165999 ↗
• MalfunctionAug 6, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165775 ↗
• InjuryJul 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOSURE AND SONATA PROCEDURE ON (B)(6) 2026. THE PROCEDURE WAS INITIATED USING A MYOSURE DEVICE FOR A 8CM FIBROID. DUE TO THE FIBROID BEING CALCIFIED IT WAS DIFFICULT TO RESECT. THE PHYSICIAN THEN USED THE SONATA DEVICE TO SOFTEN THE FIBROID. THE PHYSICIAN THEN RETURNED TO USING THE MYOSURE DEVICE TO START RESECTING THE REMAINDER OF THE FIBROID, WHEN IT WAS NOTED THAT THE PHYSICIAN RESECTED THE POSTERIOR WALL OF THE UTERUS. THE PHYSICIAN THEN CHOSE TO PERFORM LAPAROSCOPY AND CONFIRMED THE UTERINE PERFORATION. IT WAS CONFIRMED THAT THERE IS NO INJURY TO THE RECTUM. THE PHYSICIAN THEN SUTURED THE UTERINE PERFORATION. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. LATER THAT EVENING, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND WAS UNREMARKABLE. TWO LABORATORY STUDIES SHOWED THE PATIENT WAS NONTOXIC. PAIN SUBSIDED AND THE PATIENT WAS DISCHARGED. THE PATIENT WILL BE GOING BACK TO THE HOSPITAL FOR ANOTHER LAPAROSCOPIC PROCEDURE FOR FOLLOW UP THE WEEK OF (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT PRESENTED WITH PAIN AND LOW GRADE FEVER THE FOLLOWING DAY

  Patient problems: Pain; Uterine Perforation

  MAUDE report 25763605 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2026, THE PHYSICIAN OBSERVED A SMALL AREA OF DAMAGE ON THE PATIENT'S VAGINAL TISSUE DURING THE CONCLUSION OF THE NOVASURE PROCEDURE. THE PROCEDURE INCLUDED A HYSTEROSCOPY WITH POLYPECTOMY, REMOVAL OF A SMALL FIBROID AND A NOVASURE PROCEDURE. THE PHYSICIAN NOTED THAT THE DAMAGE MAY HAVE OCCURRED DURING REMOVAL OF THE DEVICE. UPON FURTHER EVALUATION, THE AREA APPEARED TO BE DISCOLORED AND SLIGHTLY DAMAGED. THE PHYSICIAN COULD NOT CONFIRM THE DAMAGE BUT POSSIBLY THOUGHT IT WAS A LITTLE BURN. THE AREA OF DISCOLORATION WAS NOTED ON THE PATIENT'S RIGHT INNER LABIA. THE PHYSICIAN INJECTED LIDOCAINE INTO THE AFFECTED AREA. NO ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 25624946 ↗
• InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MYOSURE PROCEDURE FOR POLYP REMOVAL. ONCE THE POLYP RESECTION WAS COMPLETED, THE CAVITY APPEARED INTACT. THE PATIENT WAS THEN UNDERGOING A NOVASURE PROCEDURE, WHERE THE CAVITY INTEGRITY ASSESSMENT (CIA) TEST TOOK 15 SECONDS TO PASS AND THE ABLATION BEGAN. ABOUT 25 SECONDS INTO THE ABLATION CYCLE, THE BLOOD QUICKLY BEGAN TO INFILITRATE THE NOVASURE TUBING PASSING THE DESICCANT FILTER WHICH LED TO A VACUUM FAILURE ALERT AT 40 SECONDS. THE PHYSICIAN REMOVED THE DEVICE TO INSPECT AND SAW NO ISSUES AND PROCEEDED BY USING A SOUND TO TAP THE VACUUM RELIEF VALVE AND REINSERTED AND RESEATED THE DEVICE. UPON THE CIA WITH THE SAME DEVICE, THE BLOOD BECAME PRESENT IN THE WIDTH DIAL AND THE CIA TEST FAILED. HYSTEROSCOPIC EVALUATION WAS PERFORMED AND DID NOT INITIALLY REVEAL EVIDENCE OF PERFORATION. A SECOND NOVASURE DEVICE WAS ATTEMPTED BUT THE CIA TEST FAILED AGAIN AND THE PROCEDURE WAS ABORTED. THE PATIENT WAS SUBSEQUENTLY SCHEDULED FOR BILATERAL SALPINGECTOMY. DURING A FOLLOW UP LAPARASCOPY WAS IDENTIFIED A MINOR UTERINE PERFORATION. THE PATIENT WAS REPORTED TO BE DOING WELL POST PROCEDURE. IT WAS LATER NOTED THAT THE PATIENT WAS 4 MONTHS POSTPARTUM

  Patient problems: Uterine Perforation

  MAUDE report 25599675 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT RECEIVED A MYOSURE REACH PROCEDURE THAT WAS REPORTED UNEVENTFUL. A DIFFERENT SURGEON INFORMED LATER THAT DURING THE PROCEDURE THE PHYSICIAN MIGHT HAVE ACCIDENTALLY RESECTED BOWEL AS THE PATHOLOGY SAMPLE THAT WAS EXAMINED FROM THE PROCEDURE REVEALED BOWEL TISSUE. PATIENT RETURNED TO THE HOSPITAL THE NEXT DAY COMPLAINING OF PAIN. ADDITIONAL INFORMATION WAS RECEIVED AND THE PATIENT HAS BEEN DISCHARGED HOME AND IN THE PATHOLOGY SAMPLE FRAGMENTS OF MUSCLE AND NERVE WERE CONSISTENT WITH BOWEL WALL. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bowel Perforation; Pain; Uterine Perforation

  MAUDE report 25447767 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MYOSURE REACH AND FLUENT PRO ON (B)(6) 2026, THE PATIENT WENT INTO CARDIAC ARREST AND HAD TO BE RESUSCITATED. PATIENT HAD A PREVIOUS HISTORY OF RETAINED PRODUCTS OF CONCEPTION AND ADDITIONALLY HAD BEEN ADMITTED TO THE HOSPITAL OVER THE WEEKEND DUE TO SEPSIS FOLLOWING 2 SUCTION DILATATION AND CURETTAGE THE PREVIOUS WEEKEND. 5 MINUTES INTO THE PROCEDURE WHILE BEING UNDER ANESTHESIA THE PATIENT HAD SUDDEN DESATURATION AND CARDIOVASCULAR COLLAPSE. THE TEAM WAS ABLE TO SUCCESSFULLY RESUSCITATE AND STABILIZE THE PATIENT. THE DEFICIT AT THE TIME OF THE CARDIOVASCULAR COLLAPSE WAS READING 3065 ML WITH STAFF ESTIMATING APPROXIMATELY 1000 ML OF SPILLAGE ON THE FLOOR. WHEN THE PATIENT WENT INTO CARDIAC ARREST THE PATIENT LACKED PULSE AND OXYGEN FOR ONE MINUTE. DURING THE PROCEDURE THE PATIENT´S OXYGEN SATURATION DROPPED TO 30%, PROMPTING THE ANESTHESIOLOGIST TO CALL FOR A CRASH CART. TO ACCOMMODATE THE EMERGENCY EQUIPMENT THE FLUENT PROCEDURE WAS ENDED, PUSHED AWAY FROM THE PATIENT. AN ABDOMINAL ULTRASOUND WAS PERFORMED BY A NON-SCRUBBED SURGEON WHICH REVEALED NO INTERNAL FLUID ACCUMULATION. AT THE TIME TOTAL FLUID READ AT 5845 ML. CUTTING TIME WAS 4 MINUTES AND

  Patient problems: Cardiac Arrest; Pulmonary Embolism; Sepsis

  MAUDE report 25446700 ↗
• InjuryApr 30, 2026Failure to Obtain Sample; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON APRIL 23, 2026, THE PHYSICIAN STARTED SAMPLING THE ENDOMETRIUM WITH THE DEVICE. THE SUCTION WAS REPORTED TO BE WORKING FINE INITIALLY. HOWEVER, AFTER SUCKING A LARGER PIECE OF TISSUE, IT WAS REPORTED THAT THE DEVICE STOPPED SUCTIONING. THERE WAS NO FLUID GOING THROUGH THE TISSUE SOCK AND LITTLE CLUMPS OF TISSUE WERE STUCK IN THE LINE. A SMALL PIECE OF TISSUE WAS LOST. THE CAVITY WAS CLOUDY WITH LITTLE PIECES OF TISSUES. A SECOND DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25047122 ↗
• MalfunctionApr 11, 2026Break

  IT WAS REPORTED DURING A MYOSURE PROCEDURE ON (B)(6) 2025, THAT THE CUTTING WINDOW SNAPPED AND WAS STUCK BACK IN THE DEVICE. THERE WAS NO PATIENT HARM REPORTED. HOLOGIC AT THE TIME REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER WHICH REPLIED THAT NO PIECES HAD BEEN DETACHED AT THE TIME, AND THAT THE BLADE WAS STUCK IN THE OPEN POSITION AND NO MEDICAL INTERVENTION WAS NEEDED. THE DEVICE WAS RETURNED AND UPON INVESTIGATION ON APRIL 1, 2026, VISUAL INSPECTION WAS CONDUCTED AND THE BLADE TIP WAS NOTED TO BE BROKEN. FUNCTIONAL TESTING WAS CONDUCTED AND THE DEVICE WAS RECIPROCATING AS INTENDED. A DISSECTION TEST WAS PERFORMED, AND THE INNER CANNULA WAS OBSERVED DAMAGED AT THE TIP, AND SOME CALCIFIED TISSUE WAS OBSERVED INSIDE THE INNER CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24847220 ↗
• InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A MYOSURE PROCEDURE THERE WAS A PERFORATION REPORTED. THE FLUID DEFICIT WENT UP TO AROUND 1.2 LITERS DEFICIT. THE PATIENT WAS SIX WEEKS POSTPARTUM. A HYSTEROSCOPY WAS DONE AND THE PERFORATION WAS CONFIRMED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 24845975 ↗
• MalfunctionMar 31, 2026Decrease in Suction

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2024, THE PHYSICIAN REPORTED THAT THE TISSUE REMOVAL DEVICE WAS NOT WORKING PROPERLY. A NEW DEVICE WAS RETRIEVED AND COMPLETED THE PROCEDURE. NO PATIENT INJURY REPORTED DURING THE PROCEDURE. THE DEVICE WAS RETURNED FOR INVESTIGATION AND ON MARCH 5TH 2025, VISUAL INSPECTION WAS CONDUCTED, AND A ORANGE PIECE OF PLASTIC WAS OBSERVED. FUNCTIONAL TESTING WAS CONDUCTED AND THE DEVICE WAS WORKING CORRECTLY BUT WAS NOT SUCTIONING DUE TO THE PROTECTOR FOUND INSIDE THE BLADE. INTERNAL INSPECTION WAS PERFORMED AND SCRATCHES ON THE BLADE WERE OBSERVED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749862 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A MYOSURE PROCEDURE ON (B)(6) 2026, THE PHYSICIAN WAS RESECTING A 4 CM NON-CALCIFIED FIBROID WITH OMNISCOPE. THE DEFICIT PASSED 2000 ML AND THE PHYSICIAN THEN STOPPED THE PROCEDURE. THE FLUID WAS SUCTIONED FROM DRAPE AND THE FINAL DEFICIT WAS 1700 ML. A FEW HOURS LATER, THE PATIENT WAS BLEEDING AND TRANSFERRED TO POST-ANESTHESIA CARE AT A HOSPITAL. A HYSTEROSCOPY WAS PERFORMED AND THE BLEEDING HAS STOPPED. PATIENT WAS HELD OVERNIGHT FOR OBSERVATION AND RECEIVED TWO UNITS OF BLOOD. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24734508 ↗
• MalfunctionMar 13, 2026Decrease in Suction; Obstruction of Flow

  IT WAS REPORTED DURING A MYOSURE PROCEDURE ON (B)(6), THAT THE SUCTION FAILED AND THE SUCTION TUBING HAD TO BE CUT. THERE WAS NO HARM TO THE PATIENT REPORTED. UPON INVESTIGATION ON (B)(6), IT WAS FOUND THAT THE INNER CANNULA WAS STUCK AND IT WAS BROKEN TO FIND THE BLADE POSITIONING STOP WAS INSIDE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598898 ↗
• MalfunctionMar 12, 2026

  ITEM/HANDPIECE WOULD NOT WORK. ERROR MESSAGE DISPLAYED ON SCREEN. SWITCHED OUT HANDSET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579468 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT MYOSURE, SONATA AND NOVASURE PROCEDURE ON (B)(6) 2026. POST THE PROCEDURES, THE PATIENT WENT TO THE EMERGENCY A FEW DAYS LATER AFTER THE PROCEDURE DUE TO FEVER. PATIENT IS BACK HOME AND IS DOING WELL AND FEVER IS GONE. DURING A PEER TO PEER CONSULTATION REQUEST ADDITIONAL INFORMATION WAS RECEIVED FOR THE CASES. IT WAS REPORTED THAT A PATIENT RECEIVED A CONCOMITANT PROCEDURE (NOVASURE, MYOSURE AND SONATA) ON A PATIENT, PHYSICIAN REPORTED THAT THE TREATED FIBROIDS WERE 4 AND 5 CM TYPE 2 MIOMAS POSSIBLE TYPE 1, THAT REQUIRED RESCETION PRIOR TO THE TREATMENT WITH SONATA. THE PATIENT LATER PRESENTED TO THE EMERGENCY ROOM WITH FEVER. PATIENT RECEIVED AN ULTRASOUND AND WAS STARTED ON KEFLEX AND METRONIDAZOLE. THE TREATING PHYSICIAN LATER CHANGED THE MEDICATION TO AUGMENTIN. PATIENT HAD NO OBJECTIVE SIGNS OF INFECTION BUT WAS SPIKING FEVERS IN THE MIDDLE OF THE NIGHT WITHOUT TAKING ANY MEDICATION. PATIENT COMPLAINED OF WATERY DISCHARGE. PHYSICIAN REPORTED THAT THE WATERY DISCHARGED THAT LASTS FOR SEVERAL WEEKS IS NOT UNCOMMON WITH RADIOFREQUENCY ABVLATION FOR SUBMUCOSAL FIBROIDS AND IS USUALLY NOT ASSOCIATED WITH FEVER CHILLS OR ELEVATED WHITE BLO

  Patient problems: Fever

  MAUDE report 24307588 ↗
• MalfunctionJan 28, 2026Decrease in Suction; Obstruction of Flow

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2025 THE CUSTOMER REPORTED THAT THE MYOSURE DEVICE STOPPED CUTTING HALFWAY THROUGH THE PROCEDURE AS WELL AS EXPERIENCING ISSUES WITH EXCESSIVE TORQUE. THE PROCEDURE WAS REPORTED TO HAVE BEEN COMPLETED WITH A THIRD DEVICE WITHOUT FURTHER ISSUE AND NO PATIENT INJURY REPORTED NOR MEDICAL INVESTIGATION REQUIRED. THE DEVICE WAS RETURNED FOR INVESTIGATION AND THE INVESTIGATION WAS CLOSED ON JANUARY 16TH 2026, WHICH REVEALED THAT INITIALLY THERE WERE NO SIGNS OF PHYSICAL DAMAGE AND THAT THE WINDOW WAS IN THE OPEN POSITION. INSIDE THE BLADE AND IN THE WINDOW THE POSITIONING PLUG WAS OBSERVED. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICE WAS CUTTING TISSUE BUT NOT SUCTION DURING THE TESTING PHASE. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203541 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A MYOSURE PROCEDURE ON (B)(6) 2025, THE PATIENT WAS BEING TREATED FOR A 4 CM POLYP UNDER LOCAL ANESTHESIA WITH AN EXTREMELY RETROVERTED UTERINE CAVITY WITH A MYOSURE ANGLE OF ALMOST 90. ON (B)(6) 2025, THE PATIENT STARTED TO HEMORRHAGE HEAVILY. PATIENT WAS RUSHED TO THE HOSPITAL WHERE THE HEMORRHAGE WAS STOPPED WITH EXACYL AFTER 4 POINTS OF HEMOGLOBIN. THE PATIENT DID NOT BLEED DURING THE PROCEDURE AND DID NOT BLEED FOR TWO DAYS AFTER THE PROCEDURE EITHER. PATIENT IS DOING WELL AND THE ULTRASOUND DID NOT SHOW ANYTHING UNUSUAL EXCEPT FOR A SMALL HEMATOMA/RETENTION. DEVICE WAS DISCARDED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24203530 ↗
• InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE MYOSURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN HAD A LITTLE DIFFICULTY WITH THE DILATOR BUT WAS ABLE TO DILATE. THE DEFICIT ON THE FLUENT DEVICE BEGAN TO RISE. THE PHYSICIAN THEN CHECKED THE CAVITY AND NOTICED A SMALL PERFORATION, SIZE OF THE DILATOR NEAR THE CENTER OF THE FUNDUS. THE MYOSURE REACH AND THE OMNI HYSTEROSCOPE WAS USED BY THE PHYSICIAN. THE PROCEDURE WAS THEN ABORTED. PATIENT WAS SENT TO RECOVERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 23728123 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2025, THE DEFICIT JUMPED FROM 0-900. IT WAS OBSERVED THAT A PERFORATION OCCURRED. THE PHYSICIAN LOOKED INTO THE CAVITY AND NOTED DAMAGE TO THE FALLOPIAN TUBE. PHYSICIAN CONFIRMED A FALSE PASSAGE HAD OCCURRED. THE DEVICE WAS REMOVED FROM THE PATIENT. A D&C WAS PERFORMED UNDER ULTRASOUND VISUALIZATION. PATIENT WAS DISCHARGED WITHOUT ANY FURTHER TREATMENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Fallopian Tube Perforation; Uterine Perforation

  MAUDE report 23705526 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE MYOSURE PROCEDURE ON (B)(6) 2025, THE DEVICE WAS USED TO REMOVE A FUNDAL INTRAMURAL FIBROID WHEN IT WAS NOTED THROUGH LAPAROSCOPY THAT A PERFORATION HAD OCCURRED. THE PROCEDURE WAS ABORTED ONCE THE PERFORATION WAS NOTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 23569984 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE MYOSURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN WAS WORKING ON A POST-MENOPAUSAL PATIENT AND RESECTED TWO POLYPS WITHOUT ANY ISSUE. THE PHYSICIAN THEN MOVED THE MYOSURE BLADE TO A DIFFERENT PART OF THE UTERUS FOR A TISSUE SAMPLE AND WAS HAVING DIFFICULTY RESECTING. PHYSICIAN APPLIED A SMALL AMOUNT OF PRESSURE, AND A SMALL PERFORATION OCCURRED. DEVICE WAS REMOVED FROM THE PATIENT. THE PERFORATION WAS CONFIRMED BY DIAGNOSTIC HYSTEROSCOPY. PROCEDURE WAS DEEMED COMPLETE AND THE FINAL DEFICIT WAS 365. THE PATIENT IS STILL IN THE OPERATING ROOM AND ITS UNKNOWN IF THE PATIENT WILL RECEIVE ANY FOLLOW UP TREATMENTS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 23569920 ↗