NA 7209855Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010492302), received between Mar 20, 2018 and Feb 20, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K012314); they may or may not involve this specific model.

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.

• MalfunctionFeb 20, 2019Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING THE SURGERY IT WAS NOTICED METAL SHAVINGS IN THE TISSUE AND THE DEVICE LOCKED UP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AND UNKNOWN DELAY USING A BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8356336 ↗
• MalfunctionAug 6, 2018Material Disintegration

  IT WAS REPORTED THAT THERE WAS METAL SHAVINGS COMING FROM THE INSTRUMENT. PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7752313 ↗
• MalfunctionMar 20, 2018Device Displays Incorrect Message

  IT WAS REPORTED THAT THE SURGEON WAS PERFORMING A SUB ACROMIAL DECOMPRESSION USING AN ELECTROBLADE AND VULCAN RF UNIT. THEN HE WENT TO USE THE CAUTERY FEATURE AND NOTHING HAPPENED. NO ERROR MESSAGE. HE CHECKED THE CONNECTIONS TO THE VULCAN AND ALL WERE PLUGGED IN CORRECTLY, HE CHANGED THE ELECTROBLADE AND IT DID NOT CAUTERIZE AS WELL. AN ERROR MESSAGE APPEARED ON THE VULCAN SAYING UNABLE TO DETERMINE VOLTAGE SERVICE REQUIRED. THERE WAS NO BACKUP DEVICE AVAILABLE AND NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7355929 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012314. One submission often covers many models, so check the product and lot details in each record.

• Z-2145-2012 · Jul 14, 2012 · Terminated
  Smith & Nephew 5.5 mm Dyonics Bonecutter ,Electroblade Full Radius Part Number: 7205962 Product Usage: The Dyonics Electroblade Resector is indicated for use in arthroscopic surg
• Z-2144-2012 · Jul 14, 2012 · Terminated
  Smith & Nephew Dyonics Electroblade Resector, 4.5mm Full Radius Blade, BONECUTTER Part Number: 72202213 Product Usage: The Dyonics Electroblade Resector is indicated for use in ar
• Z-0463-2012 · Nov 7, 2011 · Terminated
  Smith & Nephew 5.5mm DYONICS BONECUTTER ELECTROBLADE Resector Catalog Number: 7205962.