ViSAO® 311920115ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074154039), received between May 17, 2018 and May 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMay 17, 2018Break; Material Separation; Break; Material Separation

  A CUSTOMER REPORTED VIA A MANUFACTURER REPRESENTATIVE THAT TWO OF THREE BURS BROKE DURING A PROCEDURE. ANOTHER BUR DIDN'T HAVE ANY ISSUE. THE BROKEN CURVED BURS WERE USED WITH A "RAKING" LIKE MOVEMENT. THE PHYSICIAN COMMENTED THAT THE LOAD THAT WAS APPLIED TO THE BURS WAS CONSIDERED TO BE THE CAUSE OF THE BREAKAGE OF THE BURS. THE BURS WERE USED FOR APPROXIMATELY 10 MINUTES AND IT WAS CONFIRMED THAT THE BREAKAGE DID NOT OCCUR IMMEDIATELY. THE PHYSICIAN CLAIMED THERE WAS A LITTLE BIT OF DISSATISFACTION BECAUSE THE WAY THE BURS WERE BEING USED WAS NOT SO EXTREME. THE BROKEN PIECES WERE REMOVED BY SUCTION AND IT WAS VISIBLY CONFIRMED THAT NO PIECES REMAINED IN THE SURGICAL FIELD. THE BROKEN BURS WERE DISCARDED BY THE FACILITY. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7524722 ↗