Omni Hysteroscope 60-200Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 15420045510258), received between Aug 10, 2023 and Sep 24, 2026 — classified as 16 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Disintegration” (7 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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Insufficient Device Problem Information

  It was reported that during a MyoSure Lite and Omni procedure on (b)(6) 2026, the physician reported that after a few minutes of using the MyoSure Lite a silver residue was observed in the Uterine Cavity. After the procedure was completed the mesh was sent to pathology but nothing could be see with the naked eye. It was reported that all the residue was flushed from the cavity and that no harm to the patient occurred. No medical intervention required. Good faith efforts were completed and no additional information was received.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884265 ↗
• MalfunctionSep 22, 2026Material Disintegration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50861486 ↗
• MalfunctionSep 22, 2026Material Disintegration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860488 ↗
• MalfunctionSep 22, 2026Material Disintegration

  It was reported that the during a MyoSure procedure on (b)(6)2026, the physician observed metal shavings in the uterine cavity shortly after activating the device to begin removal of a non calcified polyp. The physician had inspected the uterine cavity with the hysteroscope before introducing the MyoSure and no metal shavings were observed at that time. After the MyoSure was introduced through the scope and activated once using the foot pedal, metal shavings were noted in the uterine cavity. The metal shavings were removed using the same MyoSure device and the procedure was completed using the same device. No other information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50853416 ↗
• MalfunctionSep 10, 2026Material Disintegration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50722925 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a patient received a Hysteroscopic procedure on (b)(6) 2026. The procedure was described as to reduce excessive bleeding and painful cramping experienced during menstrual cycle. After the procedure the patient reported that her symptoms had not improved but instead appear to become worse. Patient reported that she has experienced severe debilitating pain following the procedure. It was mentioned that the "equipment had malfunctioned". No additional details were provided. No other additional information could be obtained.

  Patient problems: Pain

  MAUDE report 50214153 ↗
• MalfunctionAug 6, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50166043 ↗
• MalfunctionAug 6, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50166016 ↗
• MalfunctionAug 6, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165975 ↗
• MalfunctionAug 6, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165797 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a NovaSure procedure was completed on an unknown date. The physician also performed hysteroscopy during the NovaSure procedure. The patient was admitted to the emergency room the day after the procedure with extreme pain. The patient was treated for the pain symptoms and was discharged after 24 hours. The patient is doing well and no additional treatment was needed. No other information is available.

  Patient problems: Pain

  MAUDE report 50071539 ↗
• InjuryJul 1, 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 25678550 ↗
• MalfunctionApr 21, 2026Material Disintegration

  IT WAS REPORTED DURING A MYOSURE PROCEDURE ON (B)(6) 2026, THAT THE PHYSICIAN OBSERVED METAL SHAVINGS IN THE CAVITY WHILE PERFORMING RESECTION. THE PHYSICIAN WAS RESECTING ADHESIONS IN THE CAVITY. PHYSICIAN USED SUCTION FROM THE DEVICE TO CLEAR THE SHAVINGS IN THE CAVITY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24942423 ↗
• 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 24429651 ↗
• InjuryFeb 16, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING AN OMNI HYSTEROSCOPE PROCEDURE ON (B)(6) 2026, THE STAFF REPORTED THAT THEY WERE USING AN OMNI HYSTEROSCOPE AND A STORZ LIGHT CORD AND VIDEO SYSTEM. THE STAFF PLACED THE HYSTEROSCOPE WITH THE ATTACHED LIGHT CORD ON THE PATIENT´S ABDOMEN WHILE SOUNDING. SMOKE WAS OBSERVED COMING FROM THE PATIENT´S ABDOMEN AND THE HYSTEROSCOPE WAS REMOVED AND IT WAS NOTICED THAT THE LIGHT CORD HAD DISCONNECTED AND THAT IT HAD BURNED THROUGH THE DRAPE AND BURNED THE PATIENT´S ABDOMEN SKIN SUPERFICIALLY. THE PATIENT WAS TREATED WITH OINTMENT AND GAUZE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT DISCHARGED THE SAME DAY. HOLOGIC REACHED OUT FOR ADDITIONAL DETAILS AND IT WAS REPORTED THAT THE BURN WAS A 1ST DEGREE BURN BUT WAS NOT AN OFFICIAL DIAGNOSIS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 24349597 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE PROCEDURE ON (B)(6) 2026, THE PHYSICIAN REPORTED THAT THE PATIENT HAD ¨DIFFERENT¨ ANATOMY AND CALLED A PARTNER AS WELL AS AN ULTRASOUND TECH TO ASSIST. ABLATION WAS COMPLETED AND A HYSTEROSCOPY USING A FLUENT AND OMNI SCOPE WAS PERFORMED PRE AND POST ABLATION WITH NO ISSUES TO NOTE NOR INCREASE IN DEFICIT WITH THE FLUENT MACHINE. PATIENT DID NOT HAD AN ENDOMETRIAL BIOPSY PRIOR PROCEDURE SO THE PHYSICIAN PERFORMED A DILATION AND CURETTAGE IN THE OPERATING ROOM. PATHOLOGY CAME BACK WITH RESULTS AS ACUTE CHRONIC INFLAMMATION. ON (B)(6), THE PATIENT COMPLAINED OF ABDOMINAL PAIN FOR WHICH DIFFERENT MEDICATIONS WERE GIVEN AT THE TIME. ON (B)(6) 2026, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH PAIN AND CONFUSION. LACTATE WAS 6.7 AND BLOOD PRESSURE PER HOSPITAL WAS ¨38/15¨. PATIENT RECEIVED AN EXPLORATORY LAPAROSCOPY AND WHEN THE TROCARS WERE INSERTED PUSS WAS OOZING AND THE ABDOMEN OF THE PATIENT WAS FULL OF PUSS. NO THERMAL INJURY WAS OBSERVED AND A SPOT IN THE CORNUAL AREA WAS OBSERVED TO HAVE FAT PRESSED AGAINST THE UTERUS. PATIENT WAS TOO DELICATE TO PERFORM A HYSTERECTOMY AND WAS INTUBATED AND BROUGHT TO THE ICU ON ANTIBI

  Patient problems: Abdominal Pain; Cardiogenic Shock; Sepsis; Septic Shock

  MAUDE report 24349205 ↗
• InjuryDec 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A NOVASURE PROCEDURE ON (B)(6) 2025, A HYSTEROSCOPY WAS PERFORMED, AND NO PERFORATION WAS NOTED. WHEN NOVASURE DEVICE WAS INSERTED, IT DID NOT PASS THE CAVITY INTEGRITY ASSESSMENT TEST. THE SCOPE WAS THEN INSERTED, AND IT WAS NOTICED THAT THERE WAS A POSSIBLE PERFORATION ON THE FUNDUS. PATIENT IS SET TO GO TO RECOVERY AND BE SENT HOME. PROCEDURE WAS ABORTED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 23877840 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A FLUENT PROCEDURE ON (B)(6) 2025, THAT THE FLUENT MACHINE MALFUNCTIONED. WHEN RUNNING FLUIDS, IT WOULD SPEED UP AND THEN STOP ALL OF A SUDDEN AND START AGAIN REALLY FAST AND THEN STOP AGAIN. THE CASE WAS ABORTED AND THE PHYSICIAN BELIEVED THERE WAS A UTERINE PERFORATION. THE PHYSICIAN CONFIRMED THAT THE OMNISCOPE DEVICE WAS BEING USED WOULD HAVE CAUSED THE PERFORATION, THE PATIENT WAS TAKEN TO POST ANESTHESIA CARE UNIT (PACU) AND THE PATIENT IS NOW DOING FINE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 23716753 ↗
• MalfunctionDec 2, 2025Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT DURING A MYOSURE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN USED THE MYOSURE LITE DEVICE TO RESECT SOME POLYPOID TISSUE AND THE OMNI SCISSORS TO HELP TAKE DOWN SOME SCARRING IN THE PATIENT'S UTERUS. WHEN THE PHYSICIAN WENT BACK IN TO TAKE FINAL PICTURES, A LONG STRAND OF METAL IN THE PATIENT'S CAVITY WAS NOTED. THE PHYSICIAN REMOVED THE SHAVINGS USING THE GRASPERS. THERE WAS NO HARM REPORTED. AN X RAY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23693176 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING THE PROCEDURE ON (B)(6) 2025, THE PHYSICIAN HAD A LITTLE DIFFICULT 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 PROCEDURE WAS THEN ABORTED. PATIENT WAS SENT TO RECOVERY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 23542486 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED DURING A MYOSURE PROCEDURE ON (B)(6) 2025, RESULTED IN A PERFORATION. THE PATIENT WAS A 61-YEAR-OLD FEMALE. THE PATIENT PRESENTED WITH A THICKENED CYSTIC ENDOMETRIUM AND WAS SCHEDULED FOR A HYSTEROSCOPY WITH DILATION AND CURETTAGE AND POSSIBLE POLYPECTOMY. A VAGINOSCOPIC APPROACH WITH HYDRO DILATION WAS PERFORMED USING A STANDARD DIAGNOSTIC HYSTEROSCOPE, FLUID BAG, ARTHROSCOPE GIVING SET. FLUID BAG IN A PRESSURE BAG 1L SALINE WAS USED WITH ARTHROSCOPE GIVING SET. A POLYP WAS IDENTIFIED AND THE OMNISCOPE WITH MYOSURE WAS INTRODUCED UNDER DIRECT VISUALIZATION. INITIALLY, THE POLYP WAS BRIEFLY VISUALIZED BUT THEN THE VIEWS BECOME UNCLEAR. THE PHYSICIAN ATTEMPTED ACTIVATION OF THE MYOSURE DEVICE TO IMPROVE VISUALIZATION, BUT THE VIEW DID NOT IMPROVE. POOR VISUALIZATION FOLLOWED BY APPEARANCE OF YELLOW TISSUE RAISED CONCERN FOR UTERINE PERFORATION. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPY FOR FURTHER ASSESSMENT. INTRAOPERATIVELY, THE PERFORATION SITE WAS IDENTIFIED AND OVER-SEWN WITH 2/0 MONOCRYL. THE POLYP WAS RESECTED WITH EXCELLENT VISUALIZATION. A REPEAT LAPAROSCOPY CONFIRMED HEMOSTASIS. THE UTERINE PERFORATION WAS 5.5 MM. THE PATIENT WAS MONITORED OVERNIGHT, REMAI

  Patient problems: Uterine Perforation

  MAUDE report 23542364 ↗
• 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 22701477 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A HYSTEROSCOPY ON (B)(6) 2025 THE PHYSICIAN REPORTED THAT A PERFORATION OCCURRED NEAR THE INTERNAL OS. SURGEON PERFORMED AN ULTRASOUND ON THE PATIENT. ADDITIONAL INFORMATION RECEIVED A DIAGNOSTIC LAPAROSCOPY WAS PERFORMED AND EVERYTHING ANATOMY WISE WAS INTACT AND NORMAL. ENDOSCOPY FLUID WAS OBSERVED DURING THE DIAGNOSTIC LAPAROSCOPY. THE PATIENT WAS DISCHARGED THE SAME DAY. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 22639469 ↗
• InjuryJun 3, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN OMNI SCOPE IN (B)(6) 2025, THE PHYSICIAN PERFORATED THE INTERNAL OS OF THE CERVIX WITH AN OMNI SCOPE. FOLLOWING PROCEDURE WAS ABORTED AND THE CASE WAS ABORTED. NO FOLLOW UP OR TREATMENT MEDICATION WAS GIVEN. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 22133241 ↗
• InjuryDec 30, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2024, THE PHYSICIAN REPORTED THAT PRIOR TO THE PROCEDURE THE PHYSICIAN SCOPED THE PATIENT USING A OMNI SCOPE AND NOTICED THAT THE PATIENT HAD A COUPLE OF FIBROIDS WHICH SHE ABLATED USING THE SONATA SYSTEM. THE PHYSICIAN THEN PROCEEDED TO PERFORM A NOVASURE PROCEDURE. PHYSICIAN WAS EXPERIENCING DIFFICULTY GETTING THE PATIENT´S WIDTH AFTER A COUPLE OF ATTEMPTS COULD ONLY GET 2.9 CM. THE DEVICE DID NOT PASS THE CAVITY INITIAL ASSESSMENT TEST AT THIS POINT THE PHYSICIAN SCOPED THE PATIENT AND OBSERVED A PERFORATION AT THE FUNDUS. PATIENT WAS DOING FINE AND BEING MONITORED. NO TREATMENT PROVIDED. DOCTOR SUSPECTED THAT THE PERFORATION HAPPENED FROM THE DISTAL TIP OF THE NOVASURE DEVICE WHEN SEATING THE DEVICE AND THAT THE PATIENT FUNDUS WAS VERY THIN.

  Patient problems: Uterine Perforation

  MAUDE report 21035808 ↗