SonaStar CFSM6-D050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841626100572), received between Sep 7, 2017 and Sep 7, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Arcing” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2017Charred; Fire; Arcing; Charred; Fire; Arcing

  A REPORT WAS RECEIVED FROM (B)(6), THE PRC DISTRIBUTOR AND LEGAL AGENT FOR MISONIX INC. THAT IS NO LONGER UNDER CONTRACT WITH MISONIX, INC. NO PATIENT OR USER INJURY WAS REPORTED. A MALFUNCTION WITH THE MONOPOLAR COAGULATION SYSTEM WIRE AND CONNECTOR WAS REPORTED. THE VERBATIM REPORT FOLLOWS: (B)(6) VERY RECENTLY RECEIVED A MALFUNCTION REPORT FROM (B)(6) HOSPITAL: WHEN USING COAG FUNCTION WITH VALLEY LAB FX, AFTER THE FOOTSWITCH WAS PRESSED, NAKED FLAME WAS FOUND AT THE CONNECTION PART BETWEEN SONASTAR AND VALLEY LAB FX , AND THE CABLE WAS BURNED AS CONFIRMED BY THE PHOTOS. THEN HEAD NURSE TURNED OFF THE SYSTEM, CHECKED BOTH SONASTAR AND RF GENERATOR, BUT FOUND THE TWO MACHINES WERE CONNECTED PROPERLY, BOTH MACHINES WERE FUNCTIONAL AND WORKED WELL. NOW THE HOSPITAL IS CONSIDERING REPORTING THIS TO (B)(6) AS AN ADVERSE EVENT. PLEASE MAKE SURE TO CONTACT THE HOSPITAL AS SOON AS POSSIBLE ABOUT THIS SITUATION, THE CONTACT PERSON AT THE HOSPITAL IS (B)(6). THE EVENT OCCURRED IN THE (B)(6). THE DATE OF THE EVENT WAS NOT REPORTED. THE PATIENT INFORMATION WAS NOT REPORTED. THE CLINICAL PROCEDURE AND PATIENT HISTORY WAS NOT REPORTED. A MALFUNCTION WAS REPORTED - BURNT MONOPOLAR CABLE. NO DE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6848191 ↗