Sonata® Sonography-Guided Transcervical Fibroid Ablation System SONATA2-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 10817929020326), received between Jul 18, 2025 and Sep 23, 2025 — classified as 45 injuries.

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 45 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON AUG 27, 2025, IT WAS INITIALLY REPORTED TO GYNESONICS BY TREATING PHYSICIAN THAT SHE PERFORMED TRANSCERVICAL FIBROID ABLATION (TFA) WITH THE SONATA® SYSTEM CONCOMITANTLY WITH A HYSTEROSCOPIC MYOMECTOMY WITH A MYOSURE® REACH DEVICE, OMNI® HYSTEROSCOPE WITH A FLUENT FLUID MANAGEMENT SYSTEM, AND ALSO A D&C PROCEDURE. TOWARDS THE END OF THE TFA PROCEDURE, THE TREATING PHYSICIAN NOTICED A BLANCHED AREA ON THE POSTERIOR LIP OF THE EXTERNAL CERVICAL OS THAT HAD SOME CHAR. THE AREA WAS NOTED AT THE 6 TO 9 O'CLOCK POSITION ON THE EXTERNAL OS AND WAS A FEW CENTIMETERS IN SIZE AND SHE ALSO NOTED A SMALL AREA IN THE VAGINAL FORNIX THAT WAS BLANCHED AND A SMALL AREA THAT WAS "DENUDED." THESE AREAS WERE NOTED AFTER THE PHYSICIAN HAD COMPLETED 4 FIBROID ABLATIONS WITH THE SONATA DEVICE. THE SONATA DEVICE WAS USED FOLLOWING AN UNREMARKABLE HYSTEROSCOPIC MYOMECTOMY OF A SMALL ANTERIOR FIBROID AND A D&C PROCEDURE. A DIAGNOSTIC HYSTEROSCOPY WAS PERFORMED AFTER OBSERVING THIS BLANCHED AREA, DOCTOR DID NOT NOTE ANY THERMAL INJURY INVOLVING THE ENDOCERVICAL CANAL. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE, GIVEN ANTIBIOTICS AND DOCTOR DID HAVE HER TRANSFERRED TO RIVERSIDE HOSPITAL FOR OBSERV

  Patient problems: Unspecified Reproductive System or Breast Problem

  MAUDE report 23124372 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS A 40 YO TYPE II DIABETIC MAINTAINED ON METFORMIN WITH A HISTORY OF AUB-L SECONDARY TO A 6.5-CM TYPE 2 FIBROID. HER HBAIC MOST RECENTLY WAS 6.7% ON (B)(6). SHE WAS TREATED WITH TFA ON (B)(6) 2024; THE CASE WAS REPORTEDLY UNREMARKABLE, PERFORMED UNDER MAC, AND FIVE ABLATIONS WERE CARRIED OUT ON THE ONE FIBROID. FROM 9:00 [?] 4:00, THE PATIENT REMAINED IN THE RECOVERY ROOM DUE TO SIGNIFICANT POSTOP PAIN BUT WAS D/C'D HOME IN STABLE CONDITION. ON (B)(6) 2024 (POD#3), THE PATIENT WAS EVALUATED IN THE EW OF AN OUTSIDE HOSPITAL DUE TO INCREASING PAIN, OBSTIPATION, INFREQUENT URINATION. SHE WAS AFEBRILE, AND DENIED NAUSEA, EMESIS, FEVER OR CHILLS. SHE DENIED RECTAL FLATUS OR A BOWEL MOVEMENT. THERE WAS NO URINARY FREQUENCY OR URGENCY. DURING THE COURSE OF HER EVALUATION, SHE WAS MEDICATED WITH TORADOL X 2, TYLENOL, DILAUDID, FENTANYL, OXYCODONE AND GABAPENTIN. W/U: WBC 5.2, PEX: SOME LOWER ABDOMINAL DISCOMFORT CT OF THE ABDOMEN AND PELVIS: ESSENTIALLY NEGATIVE (THE TREATED FIBROID WAS NOTED ALONG WITH SOME FREE FLUID IN THE CUL-DE-SAC). THERE WAS NO FREE AIR OR OTHER INTRAPERITONEAL ABNORMALITIES. THE PATIENT STARTED TO IMPROVE AND WAS SENT HOME.

  Patient problems: Constipation; Pelvic Pain; Urinary Retention

  MAUDE report 22964023 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED ON (B)(6). BEGINNING ON POD #2 (ON (B)(6), SHE DEVELOPED A LOW-GRADE FEVER AND MALAISE. WAS EVALUATED ON (B)(6) (POD#3) WITH PERSISTENT FEVERS AND FOUND TO HAVE 1/2 BC+ FOR GBS. WBC WAS WNL BUT AN ABDOMINOPELVIC CT REVEALED A 5-CM FLUID COLLECTION IN THE UTERUS, NO EVIDENCE OF BOWEL PERFORATION. AN EMBX WAS PERFORMED AND ONLY A SMALL AMOUNT OF BLOOD WAS EXPRESSED; NO PUS WAS NOTED. THE PATIENT WAS ADMITTED AND PLACED ON GENTAMICIN AND CLINDAMYCIN OVERNIGHT WITH CLINICAL IMPROVEMENT AS OF POD#4.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 22964021 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024 A PATIENT REPORTED THAT HER FIBROIDS HAVE NOT SHRUNK AND SHE IS EXPERIENCING DISCHARGE THAT SHE DID NOT HAVE BEFORE THE SURGERY.

  Patient problems: Abnormal Vaginal Discharge

  MAUDE report 22964018 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED ON (B)(6) 2024 FOR AUB A/W MULTIPLE FIBROIDS (14-WEEK UTERUS PER DR. GONZALEZ). THE PATIENT WAS TREATED WITH ELAGOLIX AND REMAINS ON IT. THE PROCEDURE TOOK 84 MINUTES AND 6 FIBROIDS WERE TREATED, THE LARGEST BEING A 6-CM TRANSMURAL FIBROID (THE OTHERS WERE ALL SMALL 1-1.5 CM INTRAMURAL [AND ONE SUBMUCOUS)] FIBROIDS). THE 6-CM FIBROID RECEIVED THREE ABLATIONS. THE PT DID WELL IN THE INTERIM WITH REDUCED AUB. ONE WEEK AGO, SHE NOTICED INCREASED LEUKORRHEA WITH ODOR. TODAY, SHE HAD A TEMP OF 100.1º AT HOME AND PASSED A CLOT WITH SOME SPOTTING. SHE WAS SENT TO THE EMERGENCY ROOM AND ADMITTED, PLACED ON IV ANTIBIOTICS AND MOTRIN. THE PATIENT IS STILL BEING EVALUATED, BUT THE TMAX WAS 100.7% AND IT IS NOT KNOWN IF SHE HAS ANY LAB ABNORMALITIES. IMAGING HAS NOT YET BEEN DONE.

  Patient problems: Abnormal Vaginal Discharge; Fever

  MAUDE report 22964015 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS A G0 WITH MORBID OBESITY WHO HAD HAD MULTIPLE ENCOUNTERS FOR FIBROID SYMPTOMS PRIOR TO BEING TREATED WITH SONATA TWO WEEKS AGO FOR A 3-CM TYPE 2 FIBROID. THE PHYSICIAN DESCRIBES HER AS A "HIGH MAINTENANCE" PATIENT WITH "LOW PAIN TOLERANCE." SHE RECENTLY COMPLAINED ABOUT A "LIGHT PERIOD" POST-TREATMENT ALONG WITH PAIN, AND WAS SEEN THE EMERGENCY ROOM 3-4 TIMES SINCE UNDERGOING TFA, AND WAS ADMITTED ON 9/16 FOR EVALUATION AND IS SCHEDULED FOR HYSTERECTOMY ON 9/20, WHICH IS WHY SHE REMAINS IN HOUSE. THERE IS NO EVIDENCE OF INFECTION-NO FEVERS, NO ELEVATED WBC. SHE WAS PLACED ON IV AMPICILLIN/SULBACTAM EMPIRICALLY AND WAS ALSO TREATED WITH TORADOL, "VAGINAL VALIUM" AND TYLENOL. BLEEDING WAS ALSO MANAGED WITH TRANEXAMIC ACID. HER HB ON ADMISSION WAS 12 MG/DL AND DROPPED AFTER HYDRATION TO 10.4. MG/DL. PER THE TREATING PHYSICIAN, THE PATIENT SIMPLY WANTS A HYSTERECTOMY AND IS NOT BEING DISCHARGED UNTIL SHE EITHER UNDERGOES HYSTERECTOMY AT THE END OF THE WEEK OR ELSE CHOOSES TO BE DISCHARGED.

  Patient problems: Menstrual Irregularities; Pelvic Pain

  MAUDE report 22964014 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON NOVEMBER 07, 2024 IT WAS INITIALLY REPORTED TO GYNESONICS THAT A PATENT WHO WAS TREATED WITH THE SONATA SYSTEM FOR 1 FIBROID AND 1 AREA OF ADENO/FIBROID ON MONDAY (B)(6) 2024 AND PATIENT CALLED PHYSICIAN ON THURSDAY (B)(6) 2024 COMPLAINING OF SEVERE PAIN AND DIFFICULTY WALKING AND GETTING UP. DOCTOR SPOKE TO GYNESONICS MEDICAL DEVICE DIRECTOR AND DOCTOR WAS GOING TO BRING THE PATIENT IN TO DO AN ULTRASOUND. ADDENDUM: UPON FOLLOWING UP THE NEXT DAY WITH DOCTOR, SHE INDICATED THAT THE PATIENT WENT TO AN OUTSIDE HOSPITAL AND SHE DOES NOT YET KNOW WHAT TRANSPIRED.

  Patient problems: Pelvic Pain

  MAUDE report 22964011 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  40 YO (B)(6) AT THE TIME OF TREATMENT ON (B)(6) 2024, FOR A 4-CM FIBROID. HAD BLEEDING WITH WATERY DISCHARGE ON (B)(6) 2024 TREATING PHYSICIAN AT THAT TIME AND SUGGESTED IT WAS LIKELY DUE TO SLOUGHING. U/S WAS NOT REMARKABLE OTHER THAN FOR SMALL FIBROIDS, CBC WNL. THE PATIENT'S SLOUGHING SX CONTINUED AND WAS PRESCRIBED TXA EARLIER IN (B)(6) 2025. ON (B)(6) 2025, THE PATIENT PRESENTED TO A DIFFERENT HOSPITAL WHERE SHE WAS DIAGNOSED WITH A TIA (RESOLVED ON ANTICOAGULATION) AND WAS ADMITTED FROM (B)(6) THROUGH (B)(6) 2025 DURING WHICH TIME SHE UNDERWENT UAE. REVIEW OF THE PATIENT'S MR TREATING PHYSICIAN NOTED A MOSTLY/ENTIRELY NON-PERFUSED FIBROID ALONG WITH A LARGELY NONPERFUSED FIBROID EXTRUDED INTO THE CAVITY. THERE ARE AT LEAST TWO FIBROIDS NOTED AND IN AGGREGATE ARE AROUND 8 CM.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 22964010 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, A PATIENT REPORTED TO GYNESONICS THAT SHE UNDERWENT A SONATA TREATMENT ON (B)(6) 2024. SHE REPORTED THAT SHE HAD MODERATE TO SEVERE PAIN FOR 8 DAYS AFTERWARDS THAT WAS MANAGED BY PRESCRIPTION PAIN MEDICINE. HOWEVER, WHILE THE PAIN IS NO LONGER SEVERE, SHE STILL HAVING SIGNIFICANT PAIN EVERY DAY. SHE IS TAKING TYLENOL AND ALEVE BUT STILL AVERAGING A 3 OR 4 OUT OF 10 ON THE PAIN SCALE DAILY. THE DAILY PAIN IS WORSE THAN MY NORMAL PERIOD PAIN WAS BEFORE THE SONATA TREATMENT. SOMETIMES THE PAIN GETS UP TO A 5 OR 6 OUT OF 10. BY CONTRAST, HER NORMAL PERIOD CRAMPS BEFORE THE SONATA RARELY WENT ABOVE A 3 OUT OF 10 ON THE PAIN SCALE. SHE ALSO REPORTED EXPERIENCING HOT FLASHES THAT WERE SEVERE AFTER THE SURGERY AND NOW ARE MODERATE.

  Patient problems: Pelvic Pain

  MAUDE report 22964009 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  5.5CM SUBMUCOSAL FIBROID TREATED. DID "GREAT "FOR 4 DAYS. THEN GOT CONSTIPATED AND WAS IN PAIN. NOW WITH WORSENING CRAMPING AND A 4X4X6CM ENDOMETRIAL STRIPE ON CT- WAS IN THE ER DUE TO THE PAIN. NECROTIC FIBROID TISSUE IS THE PHYSICIAN'S SUSPICION AND SHE IS PLANNING TO TAKE HER FOR A D&C IN THE AM. BOWEL SOUNDS NORMAL. WBC 12.8. NO FEVER; DOES NOT LOOK SICK. (B)(6) 2024: "PT DID WELL. WBC 8.2 PRIOR TO SURG. FIBROIDS EXTRUDING INTO ENDOMETRIAL CAVITY SHAVED DOWN AND MOSTLY REMOVED WITH MYOSURE XL UNDER US GUIDANCE. SHE DID NOT REQUIRE ANY EXTRA PAIN MEDS AFTER SURGERY SO FAR."

  Patient problems: Constipation; Pelvic Pain; Unspecified Reproductive System or Breast Problem

  MAUDE report 22964008 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  51 YO PT TREATED ON (B)(6) FOR AN 8.5-CM FIBROID WITH SONATA AND D/C'D HOME ON NSAIDS. POD#2 (ON (B)(6): NOTED SIGNIFICANT ABDOMINAL PAIN AND SEEN IN THE OFFICE, SENT HOME ON OXYCODONE. POD#4 (ON (B)(6): SEEN IN LOCAL URGENT CARE WITH FEVERS AND CHILLS. T ~101º, SLIGHT DECREASE IN BP. SENT TO HOSPITAL FOR ADMISSION TO A FLOOR BED. IMAGING: FLUID + GAS IN UTERUS. NO AUB OR NAUSEA OR VOMITING. EMPIRICALLY STARTED ON CLINDAMYCIN AND + GENTAMICIN. TODAY (POD#6) FELT BETTER AND WAS D/C'D HOME ON PO ABX. BC (1/2) POSITIVE FOR GPC AND GP BACILLI-FELT TO HAVE BEEN SKIN CONTAMINANTS BY ID CONSULT. MAY CONSIDER D/C'ING THE ANTIBIOTICS ALTOGETHER. ON (B)(6) 2024: PER TREATING PHYSICIAN, THE FINAL BLOOD CULTURE ID AND SENSITIVITY PLACES THE ORGANISM AS GENITAL FLORA, NOT A SKIN CONTAMINANT. THE PATIENT IS DOING WELL AT HOME BUT IS CONTINUING HER ANTIBIOTICS.

  Patient problems: Fever; Pelvic Pain; Unspecified Infection

  MAUDE report 22964005 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED ON (B)(6) 2024 FOR FOUR SYMPTOMATIC INTRAMURAL, TRANSMURAL AND SUBMUCOUS FIBROIDS RANGING IN SIZE FROM 2-5 CM. OF NOTE, THE PATIENT RECEIVED PROPHYLACTIC METRONIDAZOLE. THE CASE WAS UNCOMPLICATED. (B)(6) 2024: THE PATIENT DEVELOPED F&C BUT THEN DEFERVESCED. (B)(6) 2024: RECURRENT FEVERS AT HOME. (B)(6) 2024: PATIENT CALLED TO REPORT TEMP OF 104º F AND HAD OBVIOUS RIGORS, AND WAS SENT TO THE EW FOR EVALUATION. UPON ARRIVAL, WAS NOTED TO BE OBTUNDED, AS WELL AS AGITATED AND REQUIRED RESTRAINTS. TOX SCREEN NEGATIVE, ACETAMINOPHEN LEVELS NOT AT TOXIC LEVELS. PANCULTURED. STARTED ON BROAD SPECTRUM PARENTERAL ABX AND ADMITTED. DEVELOPED HYPOTENSION REQUIRING PRESSORS AND WAS ADMITTED TO THE ICU. IMAGING, INCLUDING ABDOMINOPELVIC CT AND AN HCT, ALL NEGATIVE. SOME LFTS SLIGHTLY ELEVATED. BY THE LATE AFTERNOON, THE PATIENT WAS MARKEDLY BETTER, NO LONGER AGITATED OR OBTUNDED, AND CONVERSING FREELY. VERY IMPORTANTLY, THERE WAS NO SIGNS/SYMPTOMS OF ENDOMETRITIS OR OTHER PELVIC INFECTION. (-) CV19; (-) INFLUENZA BC + FOR STAPHYLOCOCCUS LUGDUNENSIS AND COAGULASE (-) STREPTOCOCCUS PSEUDOPORCINUS, BOTH OF WHICH ARE SKIN FLORA. 9/11: PATIENT IS DOING MUCH BETTER AND REMAINS

  Patient problems: Bacteremia; Fever; Sepsis

  MAUDE report 22964004 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED ONE WEEK AGO FOR SEVERAL FIBROIDS REQUIRING 10 ABLATIONS PER THE SYSTEM-GENERATED PDF. SOME TIME AFTER THE PROCEDURE (THE DATE IS NOT CLEAR), THE PATIENT PRESENTED TO THE TREATING PHYSICIAN'S PARTNER IN THE EMERGENCY ROOM WITH A TEMP OF 101.4º AND A HEART RATE OF 112 BPM. SHE DIDN'T HAVE ANY LEUKOCYTOSIS, BUT LACTIC ACID WAS UP, SO THEY SENT BLOOD CULTURES AND A URINE CULTURE. BLOOD CULTURES WERE NEGATIVE. URINE CULTURE WAS POSITIVE FOR A SMALL QUANTITY (1000 CFU/CC) OF GROUP B STREP. HER REPEAT CBC 12 HRS LATER SHOWED AN INCREASE IN HER WHITE COUNT FROM 5.7 TO 11.7, ALONG WITH A LEFT SHIFT. SHE WAS PRESCRIBED DOXYCYCLINE AND METRONIDAZOLE AND DISCHARGED HOME. WHILE SHE WAS EMPIRICALLY TREATED WITH BROAD-SPECTRUM PELVIC COVERAGE ON THE POSSIBILITY OF ENDOMETRITIS, THERE WERE NO REPORTS OF ABDOMINAL FINDINGS OR OTHER STIGMATA OF INTRAUTERINE INFECTION, JUST A MODERATE FEVER WITH A SLIGHTLY ABNORMAL WHITE BLOOD CELL COUNT (NB: UP TO 11 IS WITHIN NORMAL LIMITS, GENERALLY).

  Patient problems: Fever; Unspecified Infection

  MAUDE report 22963999 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TREATING PHYSICIAN REPORTED A PATIENT WITH A FEVER OF 102.4 AND MYALGIAS CHILLS AND CAME TO ER. BLOOD CULTURES X 1 AND URINE CULTURE (10K) POSITIVE FOR GBS SUSPECT SHE HAS VAGINAL COLONIZATION, AND THAT SEEDED EITHER VIA HYSTEROSCOPY OR THRU SONATA. CTSCAN NORMAL ON ADMISSION-BUT I MAY REPEAT IT. SHE'S NOW BEEN FEBRILE FOR 48 HOURS. STILL WITH MORE UTERINE PAIN THAN I'D LIKE- BUT REPEAT BLOOD CULTURES FROM TODAY ARE PENDING. BASED ON THAT, ID WILL MAKE RECOMMENDATIONS REGARDING LENGTH OF ANTIBIOTICS." THE PATIENT WAS TREATED ON 6/14/24 AND WAS ADMITTED ON (B)(6) 2024 DUE TO THE ABOVE CHIEF COMPLAINTS. EVALUATION IS ONGOING AT THIS TIME. BASED ON THE FEVER AND UTERINE PAIN, THIS IS CONSISTENT WITH ENDOMETRITIS, LIKELY DUE TO GROUP B STREPTOCOCCUS ASCENDING INFECTION. ON (B)(6) 2024 GYNESONICS MD WAS NOTIFIED BY TREATING PHYSICIAN, THE PATIENT WAS DISCHARGED ON FRIDAY, (B)(6), 2024 WITH A DIAGNOSIS OF GROUP B STREPTOCOCCAL BACTEREMIA. SHE ALSO FELT THAT GIVEN THE PATIENT'S ABDOMINAL PAIN, THIS WAS CONSISTENT WITH ENDOMETRITIS ALTHOUGH SHE WAS NOT SURE IF IT COULD HAVE BEEN ROUTINE POSTOP PAIN AS WELL. THE PATIENT'S SECOND SET OF BLOOD CULTURES WERE NEGATIVE AND SHE WAS SWITCHED TO OR

  Patient problems: Fever; Pelvic Pain; Unspecified Infection

  MAUDE report 22963997 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT TREATED ON WHAT WE BELIEVE WAS ON (B)(6) 2023. FIBROID SIZE: 6CM. FIBROID TYPE: 2-5. ABLATIONS- 2 ABLATIONS. PER THE TREATING PHYSICIAN: THIS PATIENT WAS ALSO GIVEN AN IUD AFTER THE CASE. PATIENT DID WELL FOR 4 MONTHS AND THEN THEIR BLEEDING BECAME UNCONTROLLABLE ACCORDING TO PHYSICIAN. A FOLLOW UP MRI AND ULTRASOUND MEASURED AN 8 CM MASS (SHE WASN'T 100% SURE ON SIZE BUT THOUGHT IT HAD GROWN), WHICH WAS PARTIALLY PROLAPSING. SHE DID NOT REPORT ANY PAIN, JUST INCREASED BLEEDING. THE PATIENT HAD A HYSTERECTOMY WITH PART OF THE FIBROID ATTACHED TO A SMALL STALK.

  Patient problems: Menstrual Irregularities

  MAUDE report 22963995 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, IT WAS REPORTED THAT A PATIENT WAS TREATED WITH THE SONATA SYSTEM ENDED UP NEEDING TO GO TO THE HOSPITAL AND IS BEING TREATED CURRENTLY FOR SUSPECTED ENDOMETRITIS. THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL, ON (B)(6) 2024, WITH ORAL ANTIBIOTICS. THE PRESUMED DIAGNOSIS WAS ENDOMETRITIS, HOWEVER, SHE NEVER HAD A FEVER. ON (B)(6) 2024, GYNESONICS MEDICAL DIRECTOR (B)(4) RECEIVED ADDITIONAL INFORMATION FROM TREATING PHYSICIAN THE PATIENT WAS A 48-YEAR-OLD WOMAN WHO UNDERWENT TFA ON (B)(6) 2024. SHE HAD A HISTORY OF AMENORRHEA X MONTHS (MENOPAUSAL) BUT HAD A "SUBSTANTIAL" ENDOMETRIAL THICKNESS ON U/S; EMBX NEGATIVE FOR MALIGNANCY/HYPERPLASIA. HISTORY OF SEPTIC ABOUT 10 YEARS AGO. FIVE FIBROIDS TREATED-LARGEST AROUND 5 CM. POD # 6: CALLED WITH COMPLAINTS OF BLEEDING, FATIGUE, DYSPNEA. SEEN BY TREATING PHYSICIAN, BENIGN EXAM, CBC NOTEWORTHY FOR HB 12.1 G/DL (MINIMAL DECREASE FROM 12.4 PREOP) BUT WBC 13. AFEBRILE. POD #11: PRESENTED WITH DYSPNEA AND OTHER COMPLAINTS. PE W/U WAS NEGATIVE. PELVIC CT: FLUID WITH AIR IN PELVIS. PATIENT TACHYCARDIC TO 130'S. WBC 21 WITHOUT A LEFT SHIFT. PATIENT ADMITTED WITH A PRESUMPTIVE DIAGNOSIS OF ENDOMETRITIS. ADMITTED 4-5 DAYS (D/C

  Patient problems: Dyspnea; Unspecified Infection

  MAUDE report 22963990 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I WAS CONTACTED BY TREATING PHYSICIAN ABOUT A 30 YO PATIENT WHO WAS TREATED YESTERDAY FOR A 9-CM TYPE 3-5 FIBROID WITH TFA ALONG WITH LAPAROSCOPIC EXCISION OF AN OVARIAN BENIGN CYSTIC TERATOMA (DERMOID). THERE WERE ABOUT 5-6 ABLATIONS PLACED IN THE FIBROID AND THE SEROSA WAS OUT OF HARM'S WAY THROUGHOUT. AFTER THE UNCOMPLICATED TFA PROCEDURE, THE PATIENT UNDERWENT LAPAROSCOPIC DERMOID CYSTECTOMY WITHOUT SPILLAGE. WHILE IN THE PACU, THE PATIENT NOTED SIGNIFICANT LOWER ABDOMINAL PAIN AND WAS ADMITTED FOR PAIN CONTROL AND EVALUATION. SHE ALSO HAD URINARY RETENTION, WITH TWO POST-VOID RESIDUALS OF ~300 CC. SHE REMAINS AFEBRILE AND WITHOUT AN ELEVATED WBC. CT SCAN IS PENDING, AND AN INDWELLING FOLEY WAS PLACED. (B)(6): THIS IS NOT CONSISTENT WITH THERMAL INJURY TO THE BLADDER (NO HEMATURIA, FEVER OR LEUKOCYTOSIS). THE SIZE OF THE FIBROID PLACED THE UTERINE SEROSA BEYOND THE U/S DEPTH AND BEYOND THE REACH OF THE LARGEST ABLATION WITH THE SONATA SYSTEM. WHILE THE URINARY RETENTION COULD BE SECONDARY TO GENERAL ANESTHESIA, IT SEEMS SOMEWHAT PROLONGED FOR THAT TO HAVE BEEN THE ETIOLOGY, AND THE PAIN IS OUT OF PROPORTION, PER DR. (B)(6) DESCRIPTION, FOR EITHER TFA OR A LAPAROSCOPIC OVARIAN C

  Patient problems: Pelvic Pain; Urinary Retention

  MAUDE report 22963987 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  8-CM FIBROID TREATED TWO WEEKS AGO ON THE FRIDAY BEFORE MEMORIAL DAY. THE PATIENT CAME IN 24 HOURS LATER WITH FEVERS-WBC WNL, 102º-103º, NORMAL EXAM, SENT HOME POD #3-CAME INTO EW WITH FEVERS, 102º-103º AND HER PLATELET COUNT (PLATELETS WERE ONLY 35K). HB WNL. ADMITTED-BLOOD CULTURES WERE ALL NEGATIVE, MED CONSULT, HEME ONC ALL STUMPED. STILL SPIKING TEMPS X 48 HOURS BUT FINALLY DEFERVESCED AND SENT HOME ON ANTIBIOTICS. ALL GOOD NOW. A PLATELET COUNT BELOW 100K IS DEFINITELY ABNORMAL, AND WHEN IT GETS VERY LOW (~5K-10K), SPONTANEOUS BLEEDING IS COMMON. IT'S NOT CLEAR WHAT CAUSED THIS, NOR DOES ANYONE UNDERSTAND ITS SIGNIFICANCE IN THIS PATIENT. THERE WAS NO EVIDENCE OF INFECTION, NO ABNORMAL PHYSICAL EXAM FINDINGS, JUST ISOLATED FEVERS AND LOW PLATELETS.

  Patient problems: Fever; Thrombocytopenia

  MAUDE report 22963986 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, IT WAS REPORTED THAT A PATIENT WAS TREATED WITH THE SONATA SYSTEM PATIENT REQUIRES "URGENT LAP MYO" DUE TO POTENTIAL POST SONATA COMPLICATIONS. THE TREATING PHYSICIAN VIEWS THIS NOT AS A COMPLICATION BUT RATHER A REINTERVENTION. THE PATIENT HAS HAD A HYSTEROSCOPIC MYOMECTOMY FOR A LARGE TYPE 1 FIBROID THAT WAS NOT SUCCESSFUL SO TFA WAS PERFORMED AROUND 3/1 FOR THE 6.5-7 CM SUBMUCOUS FIBROID. IT WENT WELL AND THE PATIENT HAS SOME VAGUE URINARY COMPLAINTS BUT EVALUATION WAS UNREMARKABLE. SHE WAS SEEN IN EARLY (B)(6) DURING HER NORMAL POSTOP VISIT WITH SOME CRAMPING AND A CLOSED CERVIX. RECENTLY, SHE STARTED TO HAVE SOME SLOUGHING AS ANTICIPATED AND NOW IS FRUSTRATED BY THE CONTINUED SYMPTOMS AFTER TWO TRANSCERVICAL PROCEDURES AND WANTS A LAPAROSCOPIC MYOMECTOMY, WHICH WILL BE DONE SOON.

  Patient problems: Abnormal Vaginal Discharge

  MAUDE report 22963983 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WHO EXPERIENCED A FIBROID EXPULSION AFTER TFA. 42 Y/O WITH A 6.7 CM FIGO TYPE 2-5 UNDERWENT D&C (NO RESECTION) SONATA RFA AND PLACEMENT OF MIRENA IUD. 7 WEEKS POST OP SHE PRESENTED WITH PAIN, WATERY AND BLOODY DISCHARGE. SHE WAS SEEN IN ED ADMITTED 48 HOURS AND GIVEN ANTIBIOTIC AND ANALGESIA PASSING VERY SMALL BITS OF TISSUE. AFTER DISCHARGE SHE RETURNED TO ED PRESENTING WITH LARGE MYOMA PIECE, 4 CM, THAT ABORTED. PATHOLOGY REPORT: A. THE SPECIMEN IS RECEIVED FRESH WITH PROPER PATIENT IDENTIFICATION LABELED "UTERUS, POSSIBLE LEIOMYOMA PASSED AT HOME" AND CONSISTS OF A 4.7 X 3.8 X 2.8 CM SOLID MASS OF PINK-TAN FIBROUS TISSUE A. FINAL: FRAGMENT OF LEIOMYOMA WITH ISCHEMIC NECROSIS. AGAIN, SHE PRESENTED ABOUT 4 WEEKS LATER AND HAD SECOND PIECE OF MYOMA REMOVED FROM THE CERVICAL OS. THE SPECIMEN IS RECEIVED FRESH WITH PROPER PATIENT IDENTIFICATION LABELED "FIBROID". IT CONSISTS OF A SINGLE PIECE OF TAN-WHITE, FIRM, FIBROUS TISSUE; NECROTIC TISSUE, CONSISTENT WITH LEIOMYOMA WITH ISCHEMIC NECROSIS MEASURING 1.9 X 1.7 X 0.3 CM." PROPHYLACTIC ABX WERE NOT ADMINISTERED TO THIS PATIENT.

  Patient problems: Abnormal Vaginal Discharge; Bacteremia; Unspecified Reproductive System or Breast Problem

  MAUDE report 22929556 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WHO EXPERIENCED ENDOMETRITIS AFTER TFA. "47 Y/O HAD 3 MYOMAS : 6.5 CM FIGO TYPE 5; 3.6 FIGO TYPE 5; 2.2 FIGO TYPE 2. NO RESECTION. 11 DAYS POST OP PRESENTED W FEVER, PAIN, DISCHARGE AND TENDERNESS ON EXAM. SHE DID NOT HAVE ELEVATED WBC;HOWEVER, DUE TO TENDERNESS AND FEVER SHE WAS TREATED W ANTIBIOTIC FOR DIAGNOSIS OF ENDOMETRITIS. SHE WAS IN HOSPITAL FOR 4 DAYS, DISCHARGED ON ORAL ANTIBIOTICS " PROPHYLACTIC ABX WERE NOT ADMINISTERED TO THIS PATIENT.

  Patient problems: Abnormal Vaginal Discharge; Fever; Pelvic Pain

  MAUDE report 22929555 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SONATA PERFORMED ON (B)(6) 2023 FOR A 6CM LEFT SIDED TRANSMURAL MYOMA. PATIENT COMPLAINED OF TISSUE DISCHARGE AROUND (B)(6) 2023, IMAGING SHOWED INTRACAVITARY MYOMA/TISSUE AROUND 7-8CM IN SIZE, WAS REMOVED BY HYSTEROSCOPY AND PATHOLOGY SHOWED NECROTIC FIBROID.

  Patient problems: Unspecified Reproductive System or Breast Problem

  MAUDE report 22929554 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  44 YO WOMEN TREATED ON (B)(6) (AROUND A MONTH AGO) FOR A SYMPTOMATIC 6-CM POSTERIOR FIBROID. TFA AND HYSTEROSCOPIC MYOMECTOMY WAS PERFORMED AND THE PATIENT RECEIVED ABX PROPHYLAXIS. WAS SEEN INITIALLY IN THE EMERGENCY WARD TWO WEEKS POSTOP FOR PAIN, SELF-REPORTED FEVER (NOT DOCUMENTED) AND A MILDLY ELEVATED WBC WITH A LEFT SHIFT STARTING. GIVEN CEFTRIAXONE IN THE EW AND WENT HOME ON A 14-DAY COURSE OF DOXY + FLAGYL. IMAGING SHOWED NO ACUTE PROCESS. LAST EW VISIT WAS (B)(6) FOR BACK PAIN, BLOATING. WBC WAS 14.4 WITH A LEFT SHIFT. THE EXAMINING CLINICIAN FELT HER PAIN COMPLAINTS WERE OUT OF PROPORTION TO HER CLINICAL EXAM. A SECOND U/S WAS ALSO UNREMARKABLE (NO FREE AIR, NO COLLECTION) AND A STABLE SMALL LYMPH NODE. REVIEW OF THE PROCEDURE VIDEO WAS UNREMARKABLE-NO EVIDENCE OF EXTRAUTERINE ABLATION. SEVERAL ABLATIONS WERE MADE. LAST SEEN ON (B)(6) NO FEVERS, WBC AND U/A WERE NEGATIVE. PEX SHOWED UTERINE TENDERNESS. STILL ON DOXYCYCLINE + METRONIDAZOLE. CULTURES HAD ALL BEEN NEGATIVE UNTIL HER LAST EW VISIT ON (B)(6); HER URINE CULTURE CAME BACK POSITIVE SO SHE HAD A UTI AT THE VERY LEAST.

  Patient problems: Fever; Pelvic Pain; Urinary Tract Infection

  MAUDE report 22929553 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023 HYSTEROSCOPIC RFA OF 3 FIBROIDS, NO EM POLYP NOTED. INDENTATION OF LT EMC DUE TO FIGO GRADE 3 IM MYOMA. MIRENA PLACED. PT REPORTED SEVERE CRAMPING POD#1 WITH RESOLUTION THE FOLLOWING DAY. ON (B)(6) 2023 PRESENTED TO ER WITH SEVER PELVIC PAIN, LOW GRADE TEMP (100.5), ABNORMAL FOUL SMELLING VAGINAL DC. DX WITH UTI AND TX WITH KEFLEX, DID NOT TAKE METROGEL FOR BV. -CT DEMONSTRATED FIBROID WITHIN EMC ON (B)(6) 2023 AFVSS. SVE 4CM DILATED BY FIBROIDS. UNSUCCESSFUL ATTEMPTS OF REMOVAL IN OFFICE. ON (B)(6) 2023 TAKEN TO OR AND FIBROID REMOVED VAGINALLY VIA MORCELLATION . INVERTED MALPOSITIONED IUD REMOVED. SHAGGY EM LINING IN RIGHT LATERAL CAVITY (SUSPECTED SITE OF PROLAPSE?).

  Patient problems: Fever; Pelvic Pain; Unspecified Reproductive System or Breast Problem; Urinary Tract Infection

  MAUDE report 22929552 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION-WAS CONTACTED YESTERDAY (B)(6) BY PHYSICIAN INFORMING ME THAT SHE LEARNED ONE OF HER PATIENTS WAS EVALUATED AND TREATED AT AN OUTSIDE INSTITUTION FOR A LARGE PROLAPSED FIBROID, MANAGED WITH EXCISION. I HAD A PATIENT WHO I DID SONATA ON PRESENT TO AN OUTSIDE ER LAST WEEK; SHE HAD A 7CM PROLAPSING NECROTIC FIBROID; WAS TAKEN TO THE OR TO HAVE IT EXCISED. SONATA WAS DONE (B)(6) 2023; FIBROIDS 7.6, 6CM TM FIBROIDS, AND 4.9CM IM.

  Patient problems: Unspecified Reproductive System or Breast Problem

  MAUDE report 22929551 ↗