AVANOS MCKA2-17-100-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193493478859), received between Mar 11, 2024 and Mar 11, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Sparking” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2024Sparking; Sparking

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED ONE INCIDENCE, WHICH WAS ASSOCIATED WITH TWO SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2024-00013 FOR THE SECOND REPORT IT WAS REPORTED, THE PHYSICIAN STARTED THE RADIOFREQUENCY PROCEDURE, AND THE PROBE BEGAN TO SPARK. THE PHYSICIAN STOPPED THE PROCEDURE, AND THE TWO PROBES IN USE WERE REMOVED. THE PHYSICIAN OPENED A NEW PROBE KIT AND WAS ABLE TO COMPLETE THE PROCEDURE. NO SERIOUS INJURY OCCURRED. THE PATIENT WAS REPORTED TO HAVE A SMALL MARK LOCATED WHERE THE PROBE WAS INSERTED AND HAD FORMED A SPARK. DURING THE PROCEDURE, THE PROBE WAS HELD WITH A CLAMP WHICH WAS BELIEVED TO CAUSE A BREAK IN THE INSULATION AND SPARK. PER ADDITIONAL INFORMATION RECEIVED ON 16FEB2024, THE GROUNDING PAD WAS LOCATED ON THE PATIENT¿S POSTERIOR UPPER THIGH.

  Patient problems: Skin Discoloration

  MAUDE report 18873526 ↗
• MalfunctionMar 11, 2024Sparking; Sparking

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED ONE INCIDENCE, WHICH WAS ASSOCIATED WITH TWO SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2024-00012 FOR THE FIRST REPORT. IT WAS REPORTED, THE PHYSICIAN STARTED THE RADIOFREQUENCY PROCEDURE, AND THE PROBE BEGAN TO SPARK. THE PHYSICIAN STOPPED THE PROCEDURE, AND THE TWO PROBES IN USE WERE REMOVED. THE PHYSICIAN OPENED A NEW PROBE KIT AND WAS ABLE TO COMPLETE THE PROCEDURE. NO SERIOUS INJURY OCCURRED. THE PATIENT WAS REPORTED TO HAVE A SMALL MARK LOCATED WHERE THE PROBE WAS INSERTED AND HAD FORMED A SPARK. DURING THE PROCEDURE, THE PROBE WAS HELD WITH A CLAMP WHICH WAS BELIEVED TO CAUSE A BREAK IN THE INSULATION AND SPARK. PER ADDITIONAL INFORMATION RECEIVED ON 16FEB2024, THE GROUNDING PAD WAS LOCATED ON THE PATIENT¿S POSTERIOR UPPER THIGH.

  Patient problems: Skin Discoloration

  MAUDE report 18873523 ↗