iVAS 0306530000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252158783), received between Aug 10, 2018 and Oct 28, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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.

• InjuryOct 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE PLASTIC HANDLED BROKE OFF DURING THE PROCEDURE. PATIENT WAS TRANSPORTED TO ANOTHER FACILITY TO GET A HAMMER TO REMOVE THE BROKEN OFF PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551802 ↗
• MalfunctionApr 26, 2021Fracture; Fracture

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE OR CUTTING ACCESSORY FRACTURED. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: Foreign Body In Patient

  MAUDE report 11728517 ↗
• MalfunctionAug 10, 2018Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE THE TIP OF THE DEVICE BROKE OFF IN THE PATIENT. THERE WAS NO IMPACT REPORTED TO THE PATIENT. ATTEMPTS FOR ADDITIONAL INFORMATION ARE BEING MADE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7773697 ↗