Versajet 66800472Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00040565125473), received between Sep 8, 2021 and Sep 28, 2021 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 28, 2021Break; Break

  IT WAS REPORTED THAT THE FOOT PEDAL CORD OF A VERSAJET II MULTIFUNCTION FOOTSWITCH IS BROKEN AT THE STRAIN RELIEF OF THE PEDAL END, IT NEEDS TO BE REPAIRED OR EXCHANGE THE FOOT PEDAL. AS THIS HAPPENED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12543664 ↗
• MalfunctionSep 8, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT, THE FOOD PEDAL OF A FOOTSWITCH, MULTI-FUNCTION, VERSAJET II WAS NOT FUNCTIONING PROPERLY AND WOULD NOT CONTROL DEVICE. AS THIS HAPPENED IN A MARKETING DEMONSTRATION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439986 ↗