DYONICS RF, WHIRLWIND 72202139Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010625045), received between Dec 12, 2017 and Jul 11, 2018 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2018Device Displays Incorrect Message

  IT WAS REPORTED THAT AN ERROR E5 APPEARS ON THE SCREEN INDICATING THAT THE PROBE IS REUSED BUT IT IS NEW. PROBLEM RESULTED IN AN EXTENDED SURGICAL TIME. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679457 ↗
• MalfunctionJul 11, 2018Device Displays Incorrect Message

  IT WAS REPORTED THAT AN ERROR E5 APPEARS ON THE SCREEN INDICATING THAT THE PROBE IS REUSED BUT IT IS NEW. PROBLEM RESULTED IN AN EXTENDED SURGICAL TIME. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679384 ↗
• MalfunctionJul 11, 2018Device Displays Incorrect Message

  IT WAS REPORTED THAT AN ERROR E5 APPEARS ON THE SCREEN INDICATING THAT THE PROBE IS REUSED BUT IT IS NEW. PROBLEM RESULTED IN AN EXTENDED SURGICAL TIME. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7679273 ↗
• MalfunctionJul 11, 2018Device Displays Incorrect Message

  IT WAS REPORTED THAT AN ERROR E5 APPEARS ON THE SCREEN INDICATING THAT THE PROBE IS REUSED BUT IT IS NEW. PROBLEM RESULTED IN AN EXTENDED SURGICAL TIME. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7678070 ↗
• MalfunctionJul 11, 2018Device Displays Incorrect Message

  IT WAS REPORTED THAT AN ERROR E5 APPEARS ON THE SCREEN INDICATING THAT THE PROBE IS REUSED BUT IT IS NEW. PROBLEM RESULTED IN AN EXTENDED SURGICAL TIME. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7678004 ↗
• MalfunctionDec 12, 2017Detachment Of Device Component; Component Falling

  IT WAS REPORTED THAT THE DOCTOR WAS USING THE WHIRLWIND TO PERFORM SOFT TISSUE ABLATION DURING A HIP SCOPE CASE. AFTER 2 HOURS OF INTERMITTENT USAGE, THE METAL BIT ON THE WAND DROPPED OFF. HE HAD TO USE A TISSUE GRASPER TO PICK THE BIT UP, NOTHING WAS LEFT IN THE HIP JOINT. HE CONTINUED USING THE WAND WITH NO ISSUE FOR ANOTHER 15MINS AND FINISHED THE CASE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7107971 ↗