Myosure XL for Fluent Device 50-601XLRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 15420045507654), received between Feb 8, 2021 and Jun 15, 2026 — classified as 1 death, 23 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (4 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A MYOSURE PROCEDURE ON (B)(6) 2026, THAT WHILE USING AN OMNISCOPE THE PHYSICIAN EXPERIENCED DIFFICULTY OBTAINING VISUALIZATION. THE PROCEDURE WAS CONTINUED AND THE RESECTING STARTED WHEN THE PATIENT DEVELOPED EXCESSIVE BLEEDING. MEASURES LIKE GAUZE AND SURGICAL NAPKINS WERE USED TO CONTROL BLEEDING, BUT THE BLEEDING COULD NOT BE CONTROLLED. THE PATIENT UNDERWENT HYSTERECTOMY, RECEIVED 9 UNITS OF BLOOD TRANSFUSION DURING A 10 HOUR SURGERY AND WAS ADMITTED TO THE HOSPITAL. THE NEXT DAY, THE PATIENT WAS BLEEDING AND REQUIRED INTERVENTIONAL RADIOLOGY AND CONTROLLED BLEEDING. THE PATIENT REMAINED HOSPITALIZED FOR APPROXIMATELY ONE WEEK BEFORE DISCHARGE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25506065 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6), 2026, THAT AN 85-YEAR-OLD FEMALE UNDERWENT A HYSTEROSCOPY FOR POLYP REMOVAL AND ATTEMPTED FIBROID REMOVAL. DURING THE PROCEDURE, A RAPID FLUID DEFICIT OF 500 ML WAS OBSERVED. IT WAS THEN REPORTED THAT THE PHYSICIAN WAS ABLE TO GET A SAMPLE OF THE FIBROID AND HAD VISION OF THE FIBROID BUT DECIDED TO ABORT THE CASE. THE PHYSICIAN REPORTED POSSIBLE FALSE PASSAGE BUT DID NOT BELIEVE A UTERINE PERFORATION OCCURRED. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION BECAUSE OF THE PATIENT'S AGE AND THE FLUID DEFICIT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. NO ADDITIONAL INTERVENTION WAS REPORTED AND THE PATIENT WAS REPORTED TO BE DOING WELL. NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 25447596 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED DURING A MYOSURE PROCEDURE ON (B)(6) 2026, THAT THE BLADE BROKE OFF INSIDE THE CAVITY. THE PHYSICIAN USED GRASPERS WITH SCOPE TO REMOVE THE BLADE. THE CAVITY WAS TOTALLY CLEARED. THE PROCEDURE FIRST STARTED WITH A MYOSURE REACH AND THEN SWITCHED TO A MYOSURE XL DEVICE. IT WAS REPORTED THAT THERE WERE FLUENT ALARMS AND TROUBLE SLIDING THE MYOSURE XL IN AND OUT. THE PHYSICIAN THEN SWITCHED TO A SECOND MYOSURE XL DEVICE AND COMPLETED THE PROCEDURE. IT WAS NOTED THAT THE MYOSURE DEVICE HAS A CRACK. THE PHYSICIAN THEN WENT IN WITH A SCOPE TO SEE FRAGMENTED PIECES OF THE BLADE. IT IS UNKNOWN WHICH MYOSURE XL DEVICE HAD THE FRAGMENTED PIECES OF THE BLADE NOTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25036672 ↗
• MalfunctionApr 29, 2026Break

  IT WAS REPORTED DURING A MYOSURE PROCEDURE ON (B)(6) 2026, THAT THE BLADE BROKE OFF INSIDE THE CAVITY. THE PHYSICIAN USED GRASPERS WITH SCOPE TO REMOVE THE BLADE. THE CAVITY WAS TOTALLY CLEARED. THE PROCEDURE FIRST STARTED WITH A MYOSURE REACH AND THEN SWITCHED TO A MYOSURE XL DEVICE. IT WAS REPORTED THAT THERE WERE FLUENT ALARMS AND TROUBLE SLIDING THE MYOSURE XL IN AND OUT. THE PHYSICIAN THEN SWITCHED TO A SECOND MYOSURE XL DEVICE AND COMPLETED THE PROCEDURE. IT WAS NOTED THAT THE MYOSURE DEVICE HAS A CRACK. THE PHYSICIAN THEN WENT IN WITH A SCOPE TO SEE FRAGMENTED PIECES OF THE BLADE. IT IS UNKNOWN WHICH MYOSURE XL DEVICE HAD THE FRAGMENTED PIECES OF THE BLADE NOTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 25036035 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A MYOSURE PROCEDURE THAT THE PHYSICIAN WAS WORKING ON REMOVING FIBROIDS USING THE MYOSURE XL WITH THE FLUENT. THE PHYSICIAN USED THE FIRST DEVICE AND FELT THAT THE BLADE HAS BECOME DULL FROM PATHOLOGY AND CHOSE TO OPEN A SECOND MYOSURE XL DEVICE TO CONTINUE. WHILE OPERATING WITH THE SECOND DEVICE, THE PHYSICIAN PULLED THE DEVICE BACK IN THE SCOPE TO VISUALIZE THE CAVITY AND THOUGHT THERE WAS A PERFORATION. TO CONFIRM, THE PHYSICIAN REMOVED THE SCOPE AND DEVICE FROM THE CAVITY AND WENT BACK IN WITH JUST THE SCOPE. WHEN PUTTING THE SCOPE BACK INTO THE CAVITY, THE DEFICIT VALUE JUMPED SIGNIFICANTLY. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THAT POINT. AFTER COLLECTING BACK ALL FLUID, THE FINAL DEFICIT WAS ROUGHLY 2075. THE PHYSICIAN DECIDED TO LOOK LAPAROSCOPICALLY TO CONFIRM PERFORATION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 24737089 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A MYOSURE PROCEDURE THAT THE PHYSICIAN WAS WORKING ON REMOVING FIBROIDS USING THE MYOSURE XL WITH THE FLUENT. THE PHYSICIAN USED THE FIRST DEVICE AND FELT THAT THE BLADE HAS BECOME DULL FROM PATHOLOGY AND CHOSE TO OPEN A SECOND MYOSURE XL DEVICE TO CONTINUE. WHILE OPERATING WITH THE SECOND DEVICE, THE PHYSICIAN PULLED THE DEVICE BACK IN THE SCOPE TO VISUALIZE THE CAVITY AND THOUGHT THERE WAS A PERFORATION. TO CONFIRM, THE PHYSICIAN REMOVED THE SCOPE AND DEVICE FROM THE CAVITY AND WENT BACK IN WITH JUST THE SCOPE. WHEN PUTTING THE SCOPE BACK INTO THE CAVITY, THE DEFICIT VALUE JUMPED SIGNIFICANTLY. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THAT POINT. AFTER COLLECTING BACK ALL FLUID, THE FINAL DEFICIT WAS ROUGHLY 2075. THE PHYSICIAN DECIDED TO LOOK LAPAROSCOPICALLY TO CONFIRM PERFORATION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 24734504 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A MYOSURE PROCEDURE ON (B)(6) 2026, THAT FROM THE BEGINNING OF THE PROCEDURE THE PHYSICIAN HAD POOR VISUALIZATION. THE PHYSICIAN BEGAN WITH A MYOSURE AND RESECTED A SMALL PORTION OF FIBROID. THE PHYSICIAN STILL DID NOT HAVE A GOOD VISUALIZATION AND WANTED TO FEEL AROUND THE CAVITY, SO THE PHYSICIAN USED A CURETTE TO DO SO. THE ANESTHESIOLOGIST ALERTED THE PHYSICIAN THAT THE PATIENT'S BLOOD PRESSURE BEGAN TO DROP. THE PHYSICIAN ELECTED TO OPEN THE PATIENT'S ABDOMEN AND DISCOVERED THAT THE PATIENT WAS HEMORRHAGING. THE PATIENT WAS THEN TAKEN TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS NOT NEEDING TO BE TRANSFERRED AND IS HEALING AND BEING MONITORED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24461426 ↗
• MalfunctionFeb 24, 2026Material Disintegration

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2026, THE PHYSICIAN WAS TREATING A LARGE FIBROID AND ADDED SOME TORQUE TO THE DEVICE. SPECS OF METAL GLITTER WERE OBSERVED IN THE CAVITY. THE DEVICE STOPPED WORKING AND 2ND DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED. THE METAL GLITTER HAD BEEN REPORTED AS EVACUATED FROM THE CAVITY. NO PATIENT INJURY WAS REPORTED AND NO ADDITIONAL MEDICATION WAS REQUIRED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24429665 ↗
• InjuryFeb 20, 2026Material Fragmentation

  IT WAS REPORTED THAT POST A MYOSURE PROCEDURE ON (B)(6) 2026, METAL SHAVINGS WERE NOTED IN THE UTERINE CAVITY. DURING THE PROCEDURE, THE WHITE CABLE CORD WAS BOUNCING AROUND, AND THE EXCESSIVE TORQUE WARNING WAS ON THE DISPLAY THROUGHOUT THE PROCEDURE. THE PHYSICIAN WAS REPORTED TO USE FORCE TO CUT THE CALCIFIED FIBROID. THE PHYSICIAN REMOVED THE SHAVINGS WITH THE OUTFLOW CHANNEL BUT WAS UNABLE TO RETRIEVE IT ENTIRELY. THE PATIENT IS STABLE AND DID NOT REQUIRE ANY ADDITIONAL MEDICATION OR IMAGING AND WAS NOT ADMITTED AFTER THE PROCEDURE. CUSTOMER REPORTED THAT THE CONCOMITANT HYSTEROSCOPE AND OUTFLOW CHANNEL WERE EXAMINED FOR ANY DAMAGE AND THAT NONE WAS OBSERVED NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24404881 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A COMBINATION OF PROCEDURES ON (B)(6) 2025 WHICH INVOLVED A MYOSURE REACH PROCEDURE USING AN OMNI HYSTEROSCOPE AND, AN ACESSA PROCEDURE. PROCEDURES WERE REPORTED AS HAVING BEEN COMPLETED SUCCESSFULLY. THE PHYSICIAN LATER REPORTED THAT THE ACESSA PROCEDURE WAS UNREMARKABLE AND THAT THE PROCEDURE INCLUDED TREATMENT OF THREE FIBROIDS RANGING FROM 1 TO 3 CM. THE PATIENT CAME BACK ON (B)(6) WITH SEVERE PELVIC PAIN, ELEVATED WHITE BLOOD CELL COUNT. A CT SCAN DID NOT SHOW ANY PERFORATION. PATIENT WAS KEPT OVERNIGHT FOR OBSERVATION AND DEVELOPED AIR IN THE ABDOMINAL CAVITY. A SURGERY WAS PERFORMED AND A 5 MM PERFORATION WAS OBSERVED ON THE SMALL BOWEL WITH SUBSEQUENT RESECTION. PATIENT WAS REPORTED AS OBESE AND NEEDED RETRACTION TO KEEP THE BOWEL OUT OF THE WAY DURING THE PROCEDURE. TREATING PHYSICIAN´S ASSUMPTION NOTED THAT THE HANDPIECE MIGHT HAVE TOUCHED THE BOWEL AFTER THE USE WHILE IT WAS STILL HOT AND THIS CAUSED A THERMAL INJURY THAT RESULTED IN A PERFORATION 12 DAYS AFTER THE SURGERY. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Bacterial Infection; Bowel Burn; Bowel Perforation

  MAUDE report 22701432 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A MYOSURE PROCEDURE ON (B)(6) 2025, DURING THE PROCEDURE HYSTEROSCOPY REVEALED A LARGE FIBROID PROTRUDING THROUGH THE CERVIX. A MYOSURE XL WAS USED TO WEAKEN THE BASE OF THE FIBROID AND SCISSORS WERE USED TO EXCISE THE FIBROID. A SECOND HYSTEROSCOPY SHOWED COMPLETE REMOVAL. WEEKS AFTER THE CASE THE PHYSICIAN INFORMED THAT THE PATIENT KEPT BLEEDING POST SURGERY AND HAD TO BE BROUGHT BACK INTO THE OPERATING ROOM ON THE SAME DAY FOR A RESECTOSCOPE ABLATION TO MINIMIZE THE BLEEDING. DEVICE WAS DISCARDED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22644530 ↗
• InjuryMar 28, 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 PHYSICIAN REPORTED THAT WHILE DOING A RESECTION OF A FIBROID LOCATED IN THE LOWER SEGMENT OF THE UTERINE CAVITY ON THE POSTERIOR WALL, THE PROCEDURE WAS GOING WELL AND AT 90% OF RESECTION, THE PHYSICIAN STARTED TO OBSERVE SMALL SPECKLES/METALLIC DUST IN THE ENDOMETRIUM. SURGEON DECIDED TO ABANDON THE REMAINING PROCEDURE AND ATTEMPTED TO FLUSH THE METALLIC PIECES WITH SALINE SOLUTION, THIS WAS NOT SUCCESSFUL. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21721398 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, AFTER A MYOSURE XL PROCEDURE WHICH WAS REPORTED AS COMPLETED SUCCESSFULLY. PATIENT RETURNED TO THE EMERGENCY ROOM COMPLAINING OF PAIN. A LAPAROSCOPY WAS PERFORMED, AND BOWEL DAMAGE WAS DISCOVERED. A GENERAL SURGEON WAS BROUGHT IN TO REPAIR THE BOWEL. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bowel Perforation; Uterine Perforation

  MAUDE report 20819728 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING A MYOSURE XL PROCEDURE THE PHYSICIAN OBSERVED METAL SHAVINGS COMING OFF FROM THE DEVICE. NO OTHER INFORMATION AVAILABLE AT THE MOMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20759184 ↗
• MalfunctionAug 7, 2024Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A MYOSURE XL PROCEDURE THE DEVICE GOT HOT AND STOPPED CUTTING, THE WHITE FLEXIBLE DRIVE CABLE MELTED BELOW THE HANDLE AND AROUND THE WIRING OF THE MYOSURE XL DEVICE. NO INJURY TO THE PATIENT OR THE PHYSICIAN WAS REPORTED. PROCEDURE WAS COMPLETED WITH A SECOND DEVICE. NO ADDITIONAL INFORMATION COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19935002 ↗
• MalfunctionJul 15, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2024, DURING THE PROCEDURE IT LOOKED AS FRAGMENTS FROM THE DEVICE ENDED UP IN THE TISSUE TRAP. THE PROCEDURE WAS ABANDONED MID CASE. NO PATIENT IMPACT WAS REPORTED FROM THIS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19740761 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6), A MYOSURE PROCEDURE WAS PERFORMED, AND DURING THE CASE, THE MYOSURE REACH AFTER APPROXIMATELY TWO MINUTES OF CUT TIME, THE TISSUE TRAP AND TUBING LEADING UP TO IT HAD LITTLE TO NO TISSUE IN IT. IT APPEARED THAT THE HANDPIECE WAS NOT RESECTING TISSUE. THE STAFF SWITCHED TO A MYOSURE XL AND AFTER CUTTING WITH THIS DEVICE FOR ANOTHER APPROXIMATELY TWO MINUTES, THE SCRUB TECH AND DOCTOR SAW WHAT APPEARED TO BE METAL SHAVINGS AND/OR A DARK-COLORED DUSTING IN THE UTERUS OF THE PATIENT. THE STAFF REPLACED THE MYOSURE XL HANDPIECE WITH A NEW ONE. THE PROCEDURE CONTINUED FOR APPROXIMATELY ANOTHER FIVE MINUTES UNTIL THE DOCTOR DECIDED THE PROCEDURE WAS COMPLETED. THE PATIENT¿S UTERUS STILL APPEARED TO HAVE A SMALL AMOUNT OF DARK MATERIAL INSIDE. THE DOCTOR WAS UNABLE TO RETRIEVE ALL THE SHAVINGS FROM THE UTERUS. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18857670 ↗
• InjurySep 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AUGUST 18TH, A MYOSURE PROCEDURE WAS PERFORMED AND THE SURGEON HAD DIFFICULTY DILATING, WHICH ENDED UP TAKING MUCH LONGER THAN NORMAL AS THEY HAD TO DILATE LARGE ENOUGH FOR THE DEVICE. THEY STARTED CUTTING FOR A FEW SECONDS AND NOTICED THAT THE FLUENT SYSTEM WAS NOT ABLE TO ADEQUATELY KEEP PRESSURE. THE SURGEON OBSERVED PERFORATION THROUGH LAPAROSCOPY AND THEY USED ENERGY TO CAUTERIZE THE BLEEDING AT THE PERFORATION SITE. THE PROCEDURE WAS ABORTED. SURGEON CONFIRMED THAT THE PERFORATION WAS CAUSED BY A BLUNT DILATOR. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 17683266 ↗
• InjuryJul 28, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON JULY 6TH, A MYOSURE PROCEDURE WAS PERFORMED, AND DURING THE PROCEDURE, THERE WAS A LOT OF RESISTANCE DEPLOYING THE CUTTING BLADE DOWN THE HYSTEROSCOPES THAT WAS BEING USED. WHEN THE PHYSICIAN HAD FINISHED RESECTING, HE ATTEMPTED TO PULL THE CUTTING BLADE TO REMOVE IT FROM THE SCOPE AND ACCIDENTALLY CUT THE PATIENT'S CERVIX. THE PATIENT RECEIVED STITCHES TO STOP THE BLEEDING AND WAS REPORTED TO BE FINE AFTER THE PROCEDURE. NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. A VIDEO WAS PROVIDED BY THE CUSTOMER IN WHICH RESISTANCE COULD BE OBSERVED IN THE INTERACTION BETWEEN THE MYOSURE BLADE AND THE HYSTEROSCOPE BUT NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Laceration(s)

  MAUDE report 17413928 ↗
• MalfunctionJun 6, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2022 A MYOSURE PROCEDURE WAS PERFORMED IN AN UNKNOWN PLACE, AND THE DEVICE BROKE DURING USE ON THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070634 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON MAY 9TH, A MYOSURE PROCEDURE WAS PERFORMED, AND METAL SHAVING WAS NOTICED DURING THE PROCEDURE. THE MATERIAL WAS CLEARED AND NO INJURY TO THE PATIENT OR STAFF. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17003990 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ON (B)(6) 2023 WITHOUT ANY COMPLICATIONS. IT WAS A MYOMECTOMY WITH MYOSURE FOLLOWED BY A LAPAROSCOPIC RFA WITH ACESSA OF ONE FIBROID AND A LAPAROSCOPIC SALPINGECTOMY. ALL PROCEDURES ANTICIPATED. A MONTH LATER THE PATIENT REPORTED PAIN WARS WORSENING AND THAT HER BLEEDING HAD IMPROVED. AT 5.5 POST OP THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM DUE TO PAIN AND FEVER. BLOOD WORK REVEALED WHITE CELL COUNT AT 20 000. A CT SCAN WAS PERFORMED WITHOUT ANY SIGNIFICANT CHANGES, NO FLUID COLLECTION, NO ABSCESS AND CHANGES AROUND THE UTERUS. THE PATIENT WAS ADMITTED TO THE HOSPITAL, PUT ON IV ANTIBIOTICS AND CURRENTLY IS HEMODYNAMICALLY STABLE. THE PATIENT WAS KEPT IN THE HOSPITAL AND SHOWED SIGNS OF IMPROVEMENT FROM THE INFECTION. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Bacterial Infection

  MAUDE report 16970106 ↗
• InjuryMay 9, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2023, THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND AT THE END OF THE PROCEDURE THE PHYSICIAN ACCIDENTALLY STOPPED ON THE FOOT PEDAL ACTIVATING THE MYOSURE DEVICE WHILE IT WAS IN THE TECHS HANDS FOR CLEANING. IT WAS REPORTED THAT THE TECH SUFFERED A FINGER INJURY. NO MORE DETAILS REGARDING THE CASE ARE AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 16899472 ↗
• MalfunctionApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 A MYOSURE PROCEDURE WAS PERFORMED, AND THERE APPEARED TO BE GLITTERY PIECES FLOATING IN THE CAVITY, THE DOCTOR CHOSE TO CONTINUE CUTTING WITH THE SAME DEVICE, AND LESS OF THE GLITTERY PIECES WERE SAW AS THE PROCEDURE CONTINUED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE. REPEAT HYSTEROSCOPY AND A NOVASURE PROCEDURE WERE PERFORMED AFTER THE MYOSURE PROCEDURE, AND THE DOCTOR REPORTED THAT THE CAVITY APPEARED CLEAR AND DID NOT SEE ANY EVIDENCE OF METAL SHAVINGS IN THE CAVITY. NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16831926 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, AFTER A MYOSURE AND A NOVASURE PROCEDURE, THE FACILITY REPORTED THAT THE PATIENT HAD HEMOGLOBIN LEVEL OF 5.5. 2 MYOSURE DEVICES WERE USED, ONE REACH AND ONE XL TO REMOVE A FIBROID. THE PATIENT WAS REPORTED AS HAVING A VERY PATULOUS CERVIX AND WAS HAVING HER PERIOD AT THE TIME OF THE PROCEDURE. AFTER THE MYOMECTOMY THE PHYSICIAN PERFORMED A NOVASURE PROCEDURE SUCCESSFULLY. ALL THE PROCEDURES WERE REPORTED SUCCESSFUL, THE PATIENT WAS ADMITTED TO THE PACU AND WAS SENT HOME THE SAME DAY. NO ADDITIONAL INFORMATION RECEIVED.

  Patient problems: Anemia

  MAUDE report 16785740 ↗