Sonata® Dispersive Electrode DE-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10817929020364), received between Apr 5, 2023 and Mar 1, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  DURING A FOLLOW UP ON (B)(6) 2024, A PATIENT RETURNED TO THEIR GYNECOLOGIST. A SMALL PAPULAR LESION WITH WHAT APPEARED TO BE A NECROTIC CRUTST ON THE RIGHT UPPER ANTERIOR THIGH WAS NOTED, WITHOUT SURROUNDING ERYTHEMA. THIS PATIENT WAS TREATED WITH THE COMPANY'S SONATA TFA SYSTEM AS WELL AS OPERATIVE HYSTEROSCOPY (MONOPOLAR RESECTOSCOPY) ON (B)(6) 2024. PER THE REPORTED INFORMATION BY THE TREATING PHYSICIAN, THE SONATA SYSTEM DISPERSIVE ELECTRODES (DES) WERE PLACED NEAR BOTH PATELLAE BY THE SAME EXPERIENCE TEAM IN THE OPERATING ROOM. THERE WERE NO ISSUES NOTE DURING THE CASE, BUT IT WAS ALSO REPORTED THAT THE HYSTEROSCOPIC LIGHT SOURCE WAS RESTING NEAR THE PATIENT'S UPPER THIGH. PATIENT INDICATED THAT THE LESION WAS NOT SIGNIFICANTLY SYMPTOMATIC AT THIS POINT. NO INFORMATION OR PICTURES OF THE WOUND CLOSER TO THE OPERATIVE DATE BUT IT WAS EVIDENT THAT THE LESION WAS LOCATED IN THE LOCATION WHERE THE DE AND LAMP WERE LOCATED. PER THE PROVIDED PICTURE TAKEN AT THIS FOLLOW UP VISIT, THE PHYSICIAN STATED THAT THE FEATURES ARE CONSISTENT WITH A 2ND DEGREE BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 18823064 ↗
• InjuryApr 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023, GYNECOLOGIST COORDINATOR REPORTED TO GYNESONICS CLINICAL SPECIALIST THAT A PATIENT HAD EXPERIENCED A SKIN BURN AFTER USE OF THE SONATA SYSTEM. THE PICTURE SHOWED THAT PIECE OF THE OUTER SKIN LAYER CAME OFF. COORDINATOR INDICATED THAT THIS OCCURRED TO ONLY ONE SIDE AND THE SKIN AROUND THE TEAR WAS RED AND HOT TO THE TOUCH. ABOUT AN HOUR LATER, CLINICAL SPECIALIST RECEIVED ADDITIONAL INFORMATION, THE NURSE HAD TAKEN A PICTURE AND SHE INDICATED THAT IT WAS NOT A BURN BUT THE SKIN HAD BEEN PULLED OFF AND IT WAS MOST LIKELY DUE TO THE ADHESIVE OF THE DISPERSIVE ELECTRODE. ON MARCH 21, 2023, GYNESONICS CLINICAL SPECIALIST RECEIVED ADDITIONAL INFORMATION FROM THE DOCTOR, HE INDICATED THAT AFTER THE PATIENT'S POST-OPERATIVE APPOINTMENT ON (B)(6) 2023, THE PATIENT SEEM DOING OVERALL VERY WELL AND HER SKIN BURN WAS TREATED WITH PEROXIDE AND ANTIBIOTIC OINTMENT. DOCTOR, ALSO INDICATED THAT THE PATIENT HAD ANOTHER MINOR SKIN BLISTERING ON THE OTHER LEG.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16686776 ↗
• InjuryApr 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2023, A DOCTOR REPORTED TO GYNESONICS CLINICAL SPECIALIST THAT A PATIENT HAD EXPERIENCED POTENTIAL SKIN BURNS AFTER USE OF THE SONATA SYSTEM ON (B)(6) 2023. DURING THE PATIENT POST OPERATIVE FOLLOW UP VISIT 3 WEEKS AFTER THE SONATA SYSTEM PROCEDURE, DOCTOR INDICATED THAT THERE WAS A MARK ON THE PATIENT'S LEG POTENTIALLY CAUSED BY THE DISPERSIVE ELECTRODE. DOCTOR INDICATED THAT IT COULD BE A SKIN BURN. ON (B)(6), 2023, GYNESONICS CLINICAL SPECIALIST REACHED OUT TO DOCTOR TO ATTEMPT TO GATHER MORE INFORMATION ON THIS EVENT. DOCTOR INDICATED THAT THE PATIENT MENTIONED IN POST OP THAT SHE HAD A RED MARK. PATIENT INDICATED THAT DURING THE NEXT FEW DAYS, SHE HAD SOME REDNESS/BLISTERING TYPE IRRITATION IN THE AREA. GYNESONICS' PERSONNEL BECAME AWARE OF THIS INCIDENT ON (B)(6), 2023 AFTER THE PATIENT FOLLOW UP VISIT.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 16686773 ↗