NovaSure SureSound 2007Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 15420045501133), received between Dec 22, 2016 and Feb 16, 2026 — classified as 27 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P010013); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  HOLOGIC RECEIVED A CASE REPORT NAMED ¨SEPSIS AFTER BIPOLAR RADIOFREQUENCY ENDOMETRIAL ABLATION¨ PUBLISHED IN THE OBSTETRICS & GYNECOLOGY JOURNAL IN AUGUST 2009. THE EXACT DATE OF THE EVENT IS UNKNOWN IN 2009. THE CASE WAS A PERIMENOPAUSAL WOMAN UNDERWENT AN ENDOMETRIAL ABLATION USING A BIPOLAR RADIOFREQUENCY DEVICE. SHE PRESENTED 36 HOURS POSTOPERATIVELY WITH SEPSIS. HER CONDITION WORSENED DESPITE 18 HOURS OF INTRAVENOUS ANTIBIOTICS AND AGGRESSIVE FLUID RESUSCITATION, AND SHE UNDERWENT EXPLORATORY LAPAROTOMY AND HYSTERECTOMY. BLOOD CULTURES AND UTERINE TISSUE CULTURES GREW ESCHERICHIA COLI. THE PATIENT IMPROVED QUICKLY AFTER HYSTERECTOMY. THE PATIENT WAS REPORTED AS HEALTHY, PERIMENOPAUSAL THAT RECEIVED AN UNREMARKABLE ABLATION CYCLE, BLOOD LOSS WAS MINIMAL AND NO ANTIBIOTIC PROPHYLAXIS WAS ADMINISTERED. PATIENT HAD A NEGATIVE ENDOMETRIAL BIOPSY AND PAP TEST PERFORMED 6 WEEKS BEFORE THE PROCEDURE. PATIENT PRESENTED TO THE URGENT LOCAL CARE 36 POSTOPERATIVELY WITH FEVER, CHILLS, VOMITING, DIARRHEA, AND GENERAL MALAISE. TEMPERATURE WAS 102.3 WITH BLOOD PRESSURES AROUND 80S/40S. BLOOD CULTURES WERE OBTAINED AND THE PATIENT WAS GIVEN INTRAVENOUS DOSES OF CLINDAMYCIN, GENTAMICIN, AND CE

  Patient problems: Diarrhea; Fever; Malaise; Pulmonary Edema; Sepsis; Vomiting

  MAUDE report 24349327 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2022, A UTERINE PERFORATION WAS DISCOVERED PRIOR TO THE ABLATION. THE PERFORATION WAS CONFIRMED BY HYSTEROSCOPY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 15214335 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE THAT WAS PERFORMED ON (B)(6) 2022 A UTERINE PERFORATION WAS OBSERVED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 13395036 ↗
• MalfunctionNov 2, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON AN UNKNOWN DATE , METAL SHAVINGS WERE FOUND INSIDE THE UTERINE CAVITY , NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12739559 ↗
• InjuryAug 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE ON (B)(6) 2021, THE PHYSICIAN PERFORMED A HYSTEROSCOPY AND ABORTED DUE TO INCREASING FLUID DEFICIT. AFTER THE PHYSICIAN DECIDED TO PERFORM A NOVASURE PROCEDURE AND WAS UNABLE TO OBTAIN ADEQUATE SEAL AND COULD NOT PASS CAVITY INITIAL ASSESSMENT. THE PHYSICIAN AT THIS POINT DECIDED TO PERFORM A TRANS-VAGINAL HYSTERECTOMY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Intermenstrual Bleeding

  MAUDE report 12303307 ↗
• MalfunctionMay 14, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A NOVASURE PROCEDURE THE PHYSICIAN FOUND A HOLE IN THE ARRAY AFTER A FAILED CIA. NO ABLATION WAS PERFORMED AND THERE WAS NO HARM TO THE PATIENT REPORTED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829117 ↗
• InjuryMar 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON FEBRUARY 24TH DURING A NOVASURE PROCEDURE A UTERINE PERFORATION OCCURRED. IT WAS CONFIRMED VIA HYSTEROSCOPY AND THE PERFORATION WAS CAUTERIZED AND THE PATIENT RECEIVED ANTIBIOTICS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 11446183 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE ENDOMETRIAL ABLATION PROCEDURE ON (B)(6) 2020 THE PHYSICIAN CALLED TO REPORT AN ISSUE WITH THE DEVICE FAILING THE CAVITY INTEGRITY ASSESSMENT (CIA) TEST. THE PHYSICIAN ATTEMPTED TO PERFORM TROUBLESHOOTING STEPS TO ENSURE A COMPLETE CERVICAL SEAL INCLUDING VASELINE GAUZE AND A SECOND TENACULUM TO THE CERVIX TO OBTAIN A BETTER SEAL. THE CIA WAS ATTEMPTED AGAIN AND THE TEST HAD FAILED. THE PHYSICIAN THEN PERFORMED A HYSTEROSCOPY BEFORE OPENING A SECOND DISPOSABLE DEVICE AND NOTED THAT A UTERINE PERFORATION WAS OBSERVED AT THE FUNDUS.

  Patient problems: Uterine Perforation

  MAUDE report 10569813 ↗
• InjuryAug 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIOR TO THE ABLATION, THE CAVITY WAS VISUALIZED WITH NO ABNORMALITIES NOTED. THE ABLATION WAS COMPLETED SUCCESSFULLY, AND A HYSTEROSCOPY WAS AGAIN DONE, WITH EXCELLENT VISUALIZATION OF THE FUNDUS AND NO EVIDENCE OF PERFORATION. POSTOPERATIVELY, SHE DID WELL UNTIL DAY TWO. THE PATIENT DEVELOPED SUDDEN ONSET LOWER ABDOMINAL PAIN AND WENT TO ER. SHE WAS EVENTUALLY TAKEN TO THE OPERATING ROOM WHERE A LAPAROSCOPY WAS PERFORMED. AT THIS POINT, THERE WERE BOWEL CONTENTS IN THE ABDOMEN. GENERAL SURGERY WAS CALLED AND AN OPEN LAPAROTOMY WAS DONE, NOTING TWO PERFORATIONS IN THE ILEUM. THE UTERUS HAD TWO LOCALIZED AND CIRCULAR CAUTERY MARKS ON THE FUNDUS. THE PATIENT HAD A BOWEL RESECTION. NO ADDITIONAL DETAILS AVAILABLE AT THIS TIME.

  Patient problems: Bowel Burn; Burn, Thermal; Uterine Perforation

  MAUDE report 10401514 ↗
• InjuryApr 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIOR TO STARTING THE ABLATION, THE PHYSICIAN PERFORMED A HYSTEROSCOPY AND THE UTERUS WAS INTACT. THE PHYSICIAN THEN ATTEMPTED TO PERFORM THE ABLATION BUT THE DEVICE WOULD NOT PASS CAVITY INTEGRITY ASSESSMENT, THE PHYSICIAN SUSPECTED SHE HAD PERFORATED. THE PROCEDURE WAS THEN ABORTED. NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 9949458 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PASS CAVITY INTEGRITY ASSESSMENT TWICE. THE PHYSICIAN THEN UTILIZED VASELINE AND GAUZE IN AN ATTEMPT TO SEAL THE CERVIX TWICE BUT THE DEVICE WOULD NOT PASS CAVITY INTEGRITY ASSESMENT. THE DEVICE WAS REMOVED FROM THE PATIENT AND RESEATED, IT THEN PASSED ASSESSMENT AND THE ABLATION WAS COMPLETED. AFTER ABLATION WAS COMPLETED, A LAPAROSCOPY WAS PERFORMED TO COMPLETE A PLANNED SALPINGECTOMY. ON LAPAROSCOPY, TWO AREAS OF BLANCHING AS WELL AS A UTERINE PERFORATION WERE FOUND. GENERAL SURGEON NOTED A BURN TO THE PATIENT COLON. REPORTEDLY, THE AREA OF CONCERN WAS REMOVED AND THE RECTAL SEROSA WAS OVERSEWN. NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: Burn, Thermal; Tissue Damage; Uterine Perforation

  MAUDE report 9861047 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE ABLATION PROCEDURE, THE PHYSICIAN FELT LIKE SHE HAD PERFORATED THE PATIENT UTERUS. THE PHYSICIAN VIEWED THE PATIENT CAVITY VIA HYSTEROSCOPE AND CONFIRMED A UTERINE PERFORATION. NO MEDICAL INTERVENTION WAS NEEDED AND THE PATIENT IS EXPECTED TO RETURN FOR A FOLLOW UP VISIT TO TALK.

  Patient problems: Uterine Perforation

  MAUDE report 9013927 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN COMPLETED DILATION, CURETTAGE AND HYSTEROSCOPY PRIOR TO SEATING THE DEVICE. NO ABNORMALITIES WERE NOTED. THE DEVICE WAS INSERTED AND THE CAVITY INTEGRITY ASSESSMENT FAILED. THE PHYSICIAN VIEWED THE CAVITY HYSTEROSCOPICALLY AND FOUND TWO PERFORATION MARKS AT THE FUNDUS CORNERS. THE PERFORATIONS WERE CLOSED USING SURGIFLOW. THERE WAS NO BOWEL BURN MENTIONED. NO ADDITIONAL DETAILS AVAILABLE.

  Patient problems: Uterine Perforation

  MAUDE report 8862421 ↗
• InjuryJan 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2018 THE DEVICE DID NOT ABLATE COMPLETELY. A REPRESENTATIVE FOLLOWED UP WITH THE PHYSICIAN ON (B)(6) 2018 AND ADDITIONAL INFORMATION WAS OBTAINED. THE PHYSICIAN NOTED THAT THE CAVITY INTEGRITY ASSESSMENT (CIA) PASSED WITH NO ISSUE AND THE ABLATION WAS COMPLETED. WHEN THE PHYSICIAN TRIED TO REMOVE THE DEVICE IT SEEMED TO RETRACT INTO THE SHEATH, BUT SHE COULD NOT REMOVE IT FROM THE PATIENT. ONCE IT WAS REMOVED THE PLASTIC SHEATH LOOKED MELTED. THE CAVITY WAS VIEWED AND DID NOT LOOK ABLATED LIKE IT TYPICALLY IS. THE PHYSICIAN ALSO NOTED THAT THE CERVIX HAD SOME BURN AND THERE WAS STENOSIS. SHE TRIED GOING BACK IN WITH A SECOND DEVICE TO ABLATE WHAT WAS MISSED, BUT COULD NOT GET THE DEVICE TO ADVANCE THROUGH THE CERVIX AND ABORTED THE ATTEMPT. THE PATIENT WAS DISCHARGED HOME THE SAME DAY.

  Patient problems: Burn, Thermal

  MAUDE report 8249071 ↗
• InjuryDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE ENDOMETRIAL ABLATION, A HYSTEROSCOPY WAS PERFORMED AND THEN THE PHYSICIAN ATTEMPTED TO SEAT THE NOVASURE DEVICE. THE PHYSICIAN WAS ONLY ABLE TO ACHIEVE A WIDTH OF 2CM AND "REPEATED SEATING ATTEMPTS A FEW TIMES BEFORE MOVING TO A SECOND DEVICE." UPON USING A SECOND DEVICE THE WIDTH WAS UNCHANGED AT 2CM. ONE LAST ATTEMPT WAS MADE AND THE SECOND DEVICE OPENED TO 4.5CM. THE PHYSICIAN SUSPECTED A PERFORATION AND INSPECTED THE UTERINE CAVITY WITH A HYSTEROSCOPE AND CONFIRMED A PERFORATION. THE PROCEDURE WAS ABORTED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Uterine Perforation

  MAUDE report 8157287 ↗
• InjuryDec 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE ENDOMETRIAL ABLATION PROCEDURE A UTERINE PERFORATION WAS NOTED AS "TWO SMALL HOLES NEAR THE LEFT AND RIGHT OF THE FUNDUS." THE PERFORATION WAS FIRST RECOGNIZED WHEN THE CIA (CAVITY INTEGRITY ASSESSMENT) TEST FAILED AND THEN BY HYSTEROSCOPE VIEW OF THE CAVITY POST NOVASURE DEVICE REMOVAL. NO MEDICAL INTERVENTION WAS NEEDED AND THE PATIENT WAS DISCHARGED HOME THE SAME DAY.

  Patient problems: Uterine Perforation

  MAUDE report 8124850 ↗
• InjuryOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NOVASURE ENDOMETRIAL ABLATION, "THE DOCTOR WAS TRYING TO EXPAND THE ARRAY INSIDE THE PATIENT AND THE TWO POINTS APPEAR TO HAVE GOTTEN STUCK IN THE FUNDUS." A HYSTEROSCOPY WAS PERFORMED AND THE PATIENT DID NOT HAVE GOOD INTRAUTERINE PRESSURE SO THE PROCEDURE WAS ABORTED. ENDING FLUID DEFICIT WAS 650ML. NO TREATMENT WAS GIVEN FOR THE PERFORATION. "PATIENT IS BEING KEPT FOR POST-OPERATIVE MONITORING." NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Uterine Perforation

  MAUDE report 7992292 ↗
• InjuryJun 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN PERFORMED A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2018 AND RECEIVED AN UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TEST. THE PHYSICIAN THEN PERFORMED A HYSTEROSCOPY AND NOTED A PERFORATION. NO INTERVENTION WAS REQUIRED. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Uterine Perforation

  MAUDE report 7630116 ↗
• InjuryJun 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  "THE PATIENT CALLED 24 HOURS LATER WITH RIGORS THAT SPONTANEOUSLY RESOLVED. AT 36 HOURS POST-PROCEDURE, SHE WENT TO THE ER WITH FEVER. A CT-SCAN SHOWED ABNORMAL CHANGES IN THE MYOMETRIUM ALONG WITH FLUID AND FREE AIR IN THE PELVIS. SHE WAS TAKEN TO THE OR FOR A LAPAROTOMY. UPON ENTRY INTO THE ABDOMEN, BOWEL CONTENTS WERE NOTED. A PORTION OF BOWEL WAS ADHERENT TO THE POSTERIOR WALL OF THE UTERUS. THE BOWEL WAS DISSECTED OFF OF THE UTERINE WALL; BLANCHING OF THE UTERINE SEROSA WAS NOTED ALONG THE POSTERIOR FUNDUS CONSISTENT WITH THERMAL INJURY. A THERMAL INJURY WITH PERFORATION WAS IDENTIFIED ON THE SMALL BOWEL AT THE DISTAL ILEUM. A RESECTION WITH PRIMARY ANASTOMOSIS WAS PERFORMED. THE PATIENT WAS DISCHARGED HOME IN STABLE CONDITION AFTER ONE WEEK OF HOSPITALIZATION".

  Patient problems: Uterine Perforation

  MAUDE report 7593274 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH, MANUFACTURER'S REPORT# 1222780-2018-00151. ON 06/18/2018, IT WAS REPORTED THERE WAS NO INTERVENTION TO THE PATIENT AND THE PATIENT IS DOING WELL.

  Patient problems: Uterine Perforation

  MAUDE report 7562086 ↗
• InjuryDec 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON MEDWATCH (B)(4) BY THE USER FACILITY: "AN INCIDENT WITH A FEMALE OF (B)(6) IN (B)(6) 2017. PATIENT HAD HEAVY VAGINAL BLEEPING, CKD STAGE III ATROPHIC KIDNEY. PATIENT SUFFERED BRADYCARDIA AT ONSET OF ABLATION, LIKELY VAGAL RESPONSE TO STIMULATION. HEARTRATE NOTED TO BE 17 BPM, SA 02 99%, ETCO2 _ 20 IVP ATROPINE HAD BEEN ADMINISTERED AND EPINEPHRINE 200 MG GIVEN. PULSE CHECK PERFORMED WITH NO APPRECIABLE FEMORAL PULSE PER NURSING, THEREFORE CHEST COMPRESSIONS WERE STARTED. LARYNGEAL MASK AIRWAY REMOVED, ENDOTRACHEAL TUBE PLACED WITH + ETCO2 CONFIRMED. COMPRESSIONS OCCURRED FOR - 30 SECONDS, STOPPED AFTER PULSE, ETCO2 INCREASED TO NORMAL HR AND RHYTHM CONFIRMED. PATIENT REMAINED HEMODYNAMICALLY STABLE AND WAS EXTUBATED AFTER DISPLAYING APPROPRIATE RESPIRATORY EFFORT AND NEUROMUSCULAR RECOVERY. EKG PERFORMED IN POST-ANESTHESIA CARE UNIT DISPLAYING NORMAL SINUS RHYTHM. POSSIBLE LARYNGOSPASM, HOWEVER NO LOSS OF ETCO2 OR DESATURATION NOTED". WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

  Patient problems: Vaso-Vagal Response

  MAUDE report 7135548 ↗
• MalfunctionNov 20, 2017Defective Component; Mechanics Altered

  THE DEVICE WOULD NOT CLAMP OR LOCK. THE VENDOR SAID THAT THE DEVICE WAS DEFECTIVE. THE OPERATING ROOM RN GOT ANOTHER DEVICE. THE SECOND DEVICE WORKED PERFECTLY. THE PROCEDURE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7048374 ↗
• MalfunctionNov 17, 2017Device Operates Differently Than Expected

  WHILE USING A NOVASURE DEVICE, THE SURGEON COULDN'T PASS THE CAVITY ASSESSMENT. IF YOU DO NOT PASS THE CAVITY ASSESSMENT, YOU CANNOT PERFORM THE PROCEDURE. A SEAL WITHIN THE CERVIX MUST BE MAINTAINED FOR IT TO PASS THE CAVITY ASSESSMENT. PER SURGEON, THERE WAS NO CONCERN FOR CERVIX BEING PATULOUS NOR FOR PERFORATION. THE REP WAS CALLED AND PLACED ON SPEAKER. SHE GUIDED THE SURGEON THROUGH THE SAME STEPS SHE HAD PERFORMED PRIOR TWICE. THE REP TOLD THE SURGEON TO OBTAIN A NEW DEVICE AS THE INITIAL ONE COULD BE FAULTY. THE SURGICAL TEAM OBTAINED A SECOND DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO HARM TO THE PATIENT. THE DEVICE AND PACKAGING WERE SAVED AND WILL BE RETURNED TO THE MANUFACTURER BY CLINICAL ENGINEERING. PER SITE REPORTER: THE REPRESENTATIVE WAS MADE AWARE DURING SURGERY, AIDED IN TROUBLESHOOTING, AND ULTIMATELY SUGGESTED USING A NEW DEVICE. WE WILL COORDINATE WITH THE REP TO RETURN THE DEVICE TO HOLOGIC QUALITY TEAM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7040432 ↗
• InjuryOct 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH, MANUFACTURER'S REPORT# 1222780-2017-00260. IT WAS REPORTED THE PHYSICIAN ATTEMPTED A NOVASURE ENDOMETRIAL ABLATION ON (B)(6) 2017, AND RECEIVED SEVERAL UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS USING TWO DISPOSABLE DEVICES. THE DOCTOR PERFORMED A LAPAROSCOPY AND VISUALIZED A PERFORATION. NO INTERVENTION WAS REQUIRED AND THE PATIENT WAS DISCHARGED HOME. A HYSTEROSCOPY, DILATATION AND CURETTAGE (D&C), AND SOUNDING WITH A METAL SOUND (NOT HOLOGIC DEVICES) WERE PERFORMED PRIOR TO THE ATTEMPTED ABLATION. IT IS NOT KNOWN WHEN THIS PERFORATION OCCURRED OR WHAT INSTRUMENT MAY HAVE BEEN THE CAUSE.

  Patient problems: Uterine Perforation

  MAUDE report 6980722 ↗
• InjurySep 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN COMPLETED A NOVASURE ENDOMETRIAL ABLATION ON (B(4) 2017. THE PHYSICIAN THEN PERFORMED A HYSTEROSCOPY AND NOTED THE CERVIX AND LOWER UTERINE SEGMENT WERE ABLATED. THE PHYSICIAN ABORTED THE PROCEDURE. THE PHYSICIAN "DRAIN THE BLADDER OF THE PATIENT TO OBSERVE THE URINE. PATIENT WAS SENT TO PACU AND HE SAID HE WOULD OBSERVE HER AND START HER ON ANTIBIOTICS". THE PATIENT "SUCCESSFULLY DISCHARGED THE SAME DAY. "

  Patient problems: No Code Available

  MAUDE report 6903780 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010013. One submission often covers many models, so check the product and lot details in each record.

• Z-1094-2014 · Jan 24, 2014 · Terminated
  NovaSure Impedance Controlled Endometrial Ablation System Radiofrequency Controller, Model Number: 71978-001 Catalog Number: RFC2009 Product Usage: The NovaSure Impedance Contro