RAD® 1882916 (UDI 20763000041223)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20763000041223), received between Aug 23, 2021 and Aug 23, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Vibration” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 31, 2021Open, Classified

   There was an increase in complaints related to tip breaks and wobble/vibration.

   Z-0156-2022 · Root cause: Process control · FDA record ↗

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.

• MalfunctionAug 23, 2021Vibration; Vibration

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE THAT THE BLADE WAS NOT OSCILLATING CORRECTLY, IT LOOKED WOBBLY DURING A PROCEDURE FOR FUNCTIONAL ENDOSCOPIC SINUS SURGERY. THIS WAS NOTICED AFTER USE WHILE RE-SEATING THE BLADE INTO THE HANDPIECE. THERE WAS NO INTERVENTION PLANNED OR PERFORMED. IT WAS NOTED THAT THE PRODUCT DID HAVE CONTACT WITH THE PATIENT. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT(S). THE PATIENT WAS ALIVE - NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12354090 ↗