Sonata® Radiofrequency Ablation Handpiece RFA-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10817929020371), received between Nov 19, 2025 and Sep 10, 2026 — classified as 12 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fever; Unspecified Blood or Lymphatic problem; Unspecified Gastrointestinal Problem

  MAUDE report 50723526 ↗
• InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SONATA PROCEDURE ON (B)(6) 2026, THE PHYSICIAN REPORTED THAT A SMALL BURN OF AROUND 2 CM BY 5MM WAS OBSERVED IN THE LABIA AND A BURN OF 3 CM BY 5 MM WAS OBSERVED IN THE VULVA ON A STRAIGHT LINE. NO TREATMENT WAS REPORTED AS ADMINISTERED AND NO OTHER INFORMATION WAS AVAILABLE.

  Patient problems: Burn(s)

  MAUDE report 25798144 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A SONATA PROCEDURE ON (B)(6) 2026, THE PATIENT RECEIVED A THERMAL BURN TO THE CERVIX. NO ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AND THE PATIENT WAS REPORTED AS DOING WELL. NO OTHER DETAILS AVAILABLE.

  Patient problems: Burn(s); Intermenstrual Bleeding

  MAUDE report 25449565 ↗
• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A SONATA PROCEDURE ON (B)(6)2026, PATIENT HAD BEEN PRESCRIBED PRIOR TO THE PROCEDURE WITH ANTIBIOTICS THE DAY PRIOR AND ON THE SAME DAY WITH AUGMENTIN. LATER ON, AN UNKNOWN DATE THE PATIENT PRESENTED WITH FEVER OF 102-103 DEGREES FARENHEIT FOR WHICH SHE WENT INTO THE EMERGENCY ROOM WHERE SHE WAS DIAGNOSED WITH EXTENDED SPECTRUM BETA LACTAMASE AND E. COLI SEPSIS. AS (B)(6) 2026 THE PATIENT WAS STILL IN THE HOSPITAL IMPROVING. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Sepsis

  MAUDE report 25449318 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 PATIENTS RECEIVED SONATA PROCEDURES ON UNKNOWN DATES AND LATER WERE DIAGNOSED WITH SARCOMA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE LOCATION OF THE SARCOMA OR ANY DETAILS SURROUNDING THE CASES. NO PREVIOUS MEDICAL HISTORY WAS PROVIDED. NO INFORMATION ON STATUS OF PATIENTS.

  Patient problems: Leiomyosarcoma

  MAUDE report 25185869 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 PATIENTS RECEIVED SONATA PROCEDURES ON UNKNOWN DATES AND LATER WERE DIAGNOSED WITH SARCOMA. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE LOCATION OF THE SARCOMA OR ANY DETAILS SURROUNDING THE CASES. NO PREVIOUS MEDICAL HISTORY WAS PROVIDED. NO INFORMATION ON STATUS OF PATIENTS.

  Patient problems: Leiomyosarcoma

  MAUDE report 25185779 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A SONATA PROCEDURE ON (B)(6) 2026, THE EXACT DATE IS UNKNOWN. NO ISSUES REPORTED DURING THE PROCEDURE. THE PHYSICIAN LATER REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING INTERMITTENT PAIN FOLLOWING THE PROCEDURE. THE POSSIBLE CAUSE OF THE PAIN SUSPECTED TO BE NECROSIS FROM THE FIBROID ALTHOUGH THIS INFORMATION WAS NOT CONFIRMED. THE PATIENT WAS REFERRED TO A PAIN CLINIC IN WHICH VARIOUS MEDICATIONS WERE USED INCLUDING VAGINAL VALIUM. PATIENT RECEIVED PELVIC ULTRASOUND AND CT SCAN. NO OTHER INFORMATION COULD BE OBTAINED.

  Patient problems: Pelvic Pain

  MAUDE report 25035663 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A NOVASURE AND SONATA CONCOMITANT PROCEDURE ON (B)(6) 2026. PATIENT RECEIVED ADDITIONALLY DILATION AND CURETTAGE. THE PATIENT WAS DISCHARGED THE SAME DAY AND WAS LATER ADMITTED TO THE HOSPITAL THE NEXT DAY WITH SIGNS OF NECROSING FIBROID AND ENDOMETRITIS. PATIENT HAS BEEN IN THE HOSPITAL FOR 3 DAYS AND RECEIVING ANTIBIOTICS. THERE WERE NO SIGNS OF BOWEL NOR BLADDER INJURY. THE DIAGNOSIS OF NECROSING FIBROID AND ENDOMETRITIS CONFIRMED. A SINGLE FIBROID TREATED WITH SONATA WITH MULTIPLE OVERLAPPING ABLATIONS WITHOUT COMPLICATION. ADDITIONAL INFORMATION RECEIVED PHYSICIAN REPORTED THAT PATIENT MET THE CRITERION FOR SEPSIS. PATIENT IS IMPROVING AND REPORTED THAT PATIENT DID NOT RECEIVE PREOPERATORY ANTIBIOTICS. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Necrosis; Sepsis

  MAUDE report 24817150 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A SONATA AND NOVASURE PROCEDURE ON (B)(6) 2026. PHYSICIAN PERFORMED CONCOMITANTLY A LAPAROSCOPIC BILATERAL SALPINGECTOMY, DIAGNOSTIC HYSTEROSCOPY, DILATION AND CURETTAGE AS WELL AS A PLANNED NOVASURE AND SONATA PROCEDURE. THE SONATA PROCEDURE WAS REPORTED AS NOT HAVING EXPERIENCED ISSUES BUT THE NOVASURE WAS REPORTED AS HAVING TO USE 2 DEVICES. LATER THE PATIENT COMPLAINED OF FEVER AND CHILLS. PATIENT WAS TREATED WITH MOTRIN (IBUPROFEN) THE PATIENT CONTINUED TO EXPERIENCE SYMPTOMS AND WAS ADMITTED TO THE EMERGENCY ROOM FOR EVALUATION AND ULTIMATELY DISCHARGED. ON MARCH 11TH THE TEAM WAS NOTIFIED THAT THE PATIENT HAD BEEN ADMITTED WITH COLITIS AND BEING TREATED WITH ANTIBIOTICS AND IS BEING EXPECTED TO BE DISCHARGED DURING THE WEEK. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Chills; Fever

  MAUDE report 24619375 ↗
• 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 24307573 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PATIENT UNDERWENT A SONATA PROCEDURE ON (B)(6) 2025, AND WAS TREATED 10 DAYS LATER FOR A BOWEL PERFORATION. THE INITIAL PROCEDURE WAS PERFORMED CONCOMITANTLY WITH DILATION AND CURETTAGE AND THE PHYSICIAN REPORTED EXPERIENCING ISSUES WITH DILATION. IT WAS DETERMINED AT THE TIME DURING AN ULTRASOUND THAT THE PATIENT´S POSTERIOR FIBROID (APPROX. 6CM) WAS DISPLACING THE ENDOMETRIAL CAVITY ANTERIORLY. AFTER SUCCESSFULLY DILATING THE INTERNAL OS, THE PHYSICIAN WAS ABLE TO COMPLETE 2 ABLATIONS (3.9 X 3.2 AND 3.5 AND 2.6) WITH THE SONATA SYSTEM. THERE WERE NO PERCEIVED ISSUES AT THE END OF THE PROCEDURE AND THE PATIENT WAS SENT HOME THAT DAY. LATER THE PATIENT RETURNED AND A 1CM PERFORATION OF PROXIMAL ILEUS WAS OBSERVED. THE PATHOLOGY REPORT SHOWED THAT THERE WAS NO SIGNIFICANT SPILLAGE OF SUCCUS, THERE WAS A FIBRINOUS RIND AROUND THE PERFORATION AND A SIX CENTIMETER SEGMENT OF SMALL BOWEL RESECTED AND SIDE TO SIDE FUNCTIONAL END TO END STAPLE ANASTOMOSIS WAS CREATED. BRUISING OF THE SHORT SEGMENT OF THE PROXIMAL SIGMOID COLON WAS OBSERVED AND NO FULL THICKNESS INJURY WAS IDENTIFIED AT THIS AREA. REMINDED OF THE SIGMOID COLON WAS HEALTHY AND WITHOUT CONCERN F

  Patient problems: Bowel Perforation

  MAUDE report 24198943 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT RECEIVED A SONATA PROCEDURE ON AN UNKNOWN DATE, PATIENT HAD COME TO THE EMERGENCY ROOM A FEW DAYS AFTER THE PROCEDURE WITH PAIN AND DISCOMFORT. PATIENT WAS DIAGNOSED WITH THERMAL INJURY TO THE BOWEL WHICH RESULTED IN A SMALL BOWEL RESECTION. PATIENT WAS REPORTED IN GOOD CONDITION FOLLOWING THE RESECTION, AND NO FURTHER INTERVENTION WAS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED PATIENT REQUIRED RESECTION AND REANASTOMOSIS AND THE PATIENT WAS DOING FINE AND WAS RELEASED FROM THE HOSPITAL. PHYSICIAN REPORTED THAT THE ULTRASOUND IMAGING WAS DIFFICULT TO READ DUE TO THE PATIENT´S PRIOR UTERINE ARTERY EMBOLIZATION. DATE OF ORIGINAL PROCEDURE IS UNKNOWN AND NO LOT NUMBER AVAILABLE.

  Patient problems: Bowel Burn

  MAUDE report 23597549 ↗